Further information on EMEA documents
| Document | Comments |
The European Medicines Agency (EMEA) Committee for Human Medicinal Products (CHMP), EU published (21 April 2005) QWP Guideline on Active Substance Master File procedure revision 1. The updated guidance was adopted at the April 2005 meeting of CHMP. |
|
The EMEA published on 11 April 2005 a report from the CHMP Gene Therapy Expert Group Meeting that was held on 14-15 October 2004. http://www.emea.eu.int/pdfs/human/genetherapy/18398904en.pdf |
|
This guideline outlines the quality expectations for similar biological medicinal products as compared to a reference medicinal product which has been granted a marketing authorization. It does not address the comparability exercise for changes introduced in the manufacturing process of a given product; these are addressed by ICH Q5E. |
|
A number of draft guidance documents on the development of biosimilar products were issued by the CHMP; these follow and complement the two existing EMEA guidelines adopted in 2003. The CHMP issued a draft overarching guideline on similar biological medicinal products, which describes the EMEA approach to the development and approval of these products. As part of this, the two existing guidelines will be revised to give more detailed guidance on the comparability and biosimilarity aspects of the quality, non-clinical and clinical development of biosimilar medicinal products. CPMP/437/04 Guideline on Similar Biological Medicinal Products (Released for consultation by CHMP November 2004) In addition the Committee issued 4 concept papers that will lead to guidelines on the development of biosimilar medicinal products in the following specific classes:
The deadline for commenting on the Concept Papers on biosimilar medicinal products released in November 2004 by the CHMP was extended for one month from end of January 2005 to the end of February 2005. CHMP/146710/2004 Similar Biological Medicinal Products containing Recombinant Human Insulin - Annex to the Guideline for the Development of Similar Biological Medicinal Products containing Biotechnology Derived Proteins as Active Substance (non) Clinical Issues (Released for consultation by CHMP November 2004) http://www.emea.eu.int/pdfs/human/biosimilar/14671004en.pdf CHMP/146489/2004 Similar Biological Medicinal Products containing Recombinant Human Growth Hormone - Annex to the Guideline for the Development of Similar Biological Medicinal Products containing Biotechnology Derived Proteins as Active Substance (non) Clinical Issues (Released for consultation by CHMP November 2004) http://www.emea.eu.int/pdfs/human/biosimilar/14648904en.pdf CHMP/146664/2004 Similar Biological Medicinal Products containing Recombinant Human Erythropoietin - Annex to the Guideline for the Development of Similar Biological Medicinal Products containing Biotechnology Derived Proteins as Active Substance (non) Clinical Issues (Released for consultation by CHMP November 2004) http://www.emea.eu.int/pdfs/human/biosimilar/14666404en.pdf |
|
| EMEA/CVMP/004/04 | The Committee adopted a guideline on live recombinant vector vaccines for veterinary use further to the consideration of the comments received during the public consultation (EMEA/CVMP/004/04-FINAL). This guideline defines the requirements for the quality, safety and efficacy part of applications for marketing authorisations for vector vaccines, with particular emphasis on the properties of live recombinant vector vaccines in the target and non-target species including the natural host of the parental organism, where relevant. The guideline will particularly provide advice where the vector itself is an immunogen. EMEA/CVMP/004/04 Guideline on Live Recombinant Vector Vaccines for Veterinary Use (CVMP adopted December 2004) |
| EMEA/CVMP/VICH/1052/2004 | The European Medicines Agency (EMEA) Committee for Veterinary Medicinal Products (CVMP), EU published (16 November 2004) the draft VICH Guideline on Target Animal Safety: Examination of Live Veterinary Vaccines in Target Animals for Absence of Reversion to Virulence, CVMP/VICH/1052/2004-CONSULTATION. It was released for consultation at the November 2004 CVMP meeting. http://www.emea.eu.int/pdfs/vet/vich/10 5204en.pdf |
| EMEA/CHMP/BWP/27/04 | First Cases of BSE in USA and Canada: Risk assessment of Ruminant Materials Originating from USA and Canada The EMEA BWP published on 23 August 2004 a document entitled First Cases of BSE in USA and Canada: Risk assessment of Ruminant Materials Originating from USA and Canada. This risk assessment is regarding the use of ruminant origin materials from the USA or Canada for use in human or animal medicinal products or the manufacture thereof. There is a public health conclusion and a regulatory conclusion. From a public health perspective they concluded that the reclassification of Canada and the USA (to GBR III) does not change the level of BSE risk of bovine serum and blood derivatives significantly. The risk assessment for bovine serum and blood derivatives as performed previously is still valid. From a regulatory perspective, proposed revision 2 of the TSE Note for Guidance requires the use of non-penetrative stunning if sourcing is performed in GBR III countries. Manufacturers of bovine serum (other than fetal bovine serum, calf serum, and donor bovine serum according to this risk assessment) and blood derivatives of Canadian or US origin will be asked to investigate and confirm that this requirement (non-penetrative stunning) is complied with. From a public health perspective they concluded that the reclassification of Canada and the USA (to GBR III) does not change the level of BSE risk of any gelatin (acid or alkaline) made from bones. From a regulatory perspective, an amendment to the TSE Note for Guidance is being proposed to allow the use of acid bone gelatin from GBR III sourced bones, providing the starting materials are free of skulls, spinal cord and vertebrae. For all other ruminant materials of Canadian/US Origin (other than blood derivatives and gelatin), the change in GBR rating does not cause concern with regard to TSE safety for Category C tissues and does not significantly change the risk for Category B tissues |
| EMEA/CPMP/BWP/2879/02/rev.1 | Creutzfeldt-Jakob disease and Plasma-derived and Urine-derived Products - Revised Position Statement July 2004 EMEA CHMP published on 8 July 2004 a CHMP Position Statement on Creutzfeldt-Jakob disease and Plasma-derived and Urine-derived Medicinal Products Revision 1, EMEA/CPMP/BWP/2879/02/Rev.1. This supersedes the original CPMP Position Statement on Creutzfeldt-Jakob disease and Plasma-derived and Urine-derived Medicinal Products (EMEA/CPMP/BWP/2879/02). In this first revision there is no change to the previous position that recall of plasma derived medicinal products is not justified where a donor is later confirmed as having sporadic, familial or iatrogenic CJD. With the announcement of the first possible case of vCJD transmission by blood, several changes to the position statement have been introduced which specifically affect the manufacturing process for such products. This position statement also includes reference to urine derived products since the detection of an abnormal prion protein in the urine of animals and humans suffering from TSEs was reported in 2001. Manufacturers are required to estimate the potential of their specific manufacturing processes to reduce infectivity using a stepwise approach. In vitro assays may be useful for spiking experiments to investigate manufacturing processes and their ability to remove TSE infectivity, but it is important to correlate such results with those from infectivity assays. The available data support the reduction of infectivity by steps in the manufacturing process and manufacturers are required to estimate the potential of their manufacturing process to reduce infectivity. Firstly, they should compare their own process to those with published data on reduction of infectivity in order to estimate the theoretical potential of their specific process to reduce infectivity. If the removal capacity for a particular process can not be considered comparable to that of a published process it is recommended that manufacturers perform product specific investigational studies on key steps in their process using biochemical assays. Biochemical assays may be sufficient if a clear correlation with infectivity data has already been established for a similar process. If such a correlation is not established and the step is critical for removal of infectivity, the investigation should be confirmed using a bioassay. |
| EMEA/410/01 Rev. 3
|
Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products EMEA/410/01 Rev. 3 |
| EMEA/CVMP/004/04 Consultation | The EMEA CVMP published on 16 January 2004 a Draft Guideline prepared by the CVMP (IWP) on Live Recombinant Vector Vaccines for Veterinary Use. The document was released for consultation with a deadline for comments of July 2004. http://www.emea.eu.int/pdfs/vet/iwp/000404en.pdf |
| EMEA/CPMP/BWP/3097/02 Final
|
The EMEA CPMP published on 22 December 2003 the BWP Note for Guidance on Comparability of Medicinal Products containing Biotechnology-derived Proteins as Active Substance: Non-Clinical and Clinical Issues. This guidance on clinical and non-clinical issues was adopted at the December 2003 meeting of the Committee. The date for coming into operation is June 2004. This document discusses further the considerations for additional studies for comparability studies following changes in manufacturing processes etc. http://www.emea.eu.int/pdfs/human/ewp/309702en.pdf |
| EMEA/CPMP/BWP/3207/00 Rev 1 | The EMEA CPMP published on 22 December 2003 the revision of the BWP Note for Guidance on Comparability of Medicinal Products containing Biotechnology-derived Proteins as Active Substance: Quality Issues. This guidance on quality issues was adopted at the December 2003 meeting of the Committee. The date for coming into operation is December 2003. The document has some editorial changes compared to the previous, and also has had the paragraph regarding the difference between essential similarity and comparability removed due to the references in Directive 2001/83/EC. http://www.emea.eu.int/pdfs/human/bwp/320700en.pdf |
| CPMP/1199/02
|
The EMEA CPMP published on 7 January 2004 a document entitled Points to Consider on Xenogeneic Cell Therapy Medicinal Products. The CPMP adopted the document at its meeting in December 2003 and is the final version of the draft first made available in 2002. The content has been revised and re-ordered but all the main principles remain the same as those laid out in the draft. http://www.emea.eu.int/pdfs/human/regaffair/119902en.pdf |
| EMEA ICH Topic Q5EB
|
The EMEA published (25 November 2003) ICH Topic Q5EB, Step 2 Note for Guidance on Biotechnological/Biological Products Subject to changes in their Manufacturing Process. The document was released for information in November 2003. The deadline for comments is May 2004. It provides the principles for assessing comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance and drug product. It is intended to assist in the design and conduct of studies used to collect technical information to establish comparability. Further details are available through the link given below. http://www.emea.eu.int/pdfs/human/ich/572103en.pdf |
| CPMP/BWP/5136/03
|
A new CPMP position statement on vCJD and plasma derived medicinal products was issued in Feb 2003 (EMEA/CPMP/BWP/2879/02) stating that " it is recommended that manufacturers utilise [available data] to analyse the potential of their specific manufacturing process to reduce [TSE] infectivity. It is also highly desirable that manufacturers undertake product specific investigational studies on the key steps for plasma derived medicinal products as a precautionary measure". It is the aim of this CPMP discussion paper to provide a basis for the development of a "points to consider" document on how to investigate manufacturing processes with regard to vCJD risk. http://www.emea.eu.int/pdfs/human/bwp/513603en.pdf Further information is also available in the summary document: \\Q1NT044\common\Regulatory guidelines\EMEA Guidelines\BWP\Summary_disc_invest_manuf_plasma_derived_vCJD_dec_2003.doc |
| CPMP/BWP/5180/03
|
EMEA issued a draft note for guidance (CPMP/BWP/5180/03) on 29 October, on assessing the risk of virus transmissions in plasma-derived medicinal products. It is the new chapter 6 of CPMP/BWP/269/95 and covers the amount of a given virus that may be present in starting material versus the capacity of the manufacturing process to inactivate or remove the contaminant virus. The aim of this chapter is to outline the principles of a risk assessment for plasma derivatives and the basis for its evaluation by authorities. The potential virus input should be weighed up against the overall viral clearance capacity. The reliability of a risk assessment will depend on the extent of information available on such factors as epidemiology, viraemic titre, viral clearance steps, donor selection/exclusion, neutralising antibody content and product yield. Many of these factors may vary, and worst case scenarios should be considered. For viral clearance studies, when considering emerging viruses, if it is not possible to use the emerging virus, the use of a closely related model virus should be considered if pre-existing data were derived using virus models not representative of the emerging virus. A viral risk assessment should be performed for HIV, HBV, HCV, B19 and HAV for all new marketing applications. For products for which a marketing authorisation has already been obtained a risk assessment will be expected for HAV and B19 if claims are made regarding effective measures for this virus. If no claims are made, no risk assessment will be required. In either case, risk assessments for HIV, HBV and HCV are not required. A risk assessment will not be expected for any Albumins manufactured by an established process. A risk assessment should be performed whenever post-pooling information indicates a contaminated donation has entered the plasma pool. For emerging viruses, an appropriate risk assessment should be made with reference to any available position statement. Any comments on this draft document should be submitted by end Jan 2004 to the BWP. http://www.emea.eu.int/pdfs/human/bwp/518003en.pdf |
| CPMP/1199/02 | Points to consider on xenogeneic cell therapy medicinal products was released for a 6-month consultation in Nov 2002, the deadline for comments was May 2003. Following the moratorium on xenogeneic cell therapy in Europe this guideline indicates a move towards acceptance of such therapies. Concern is highlighted on the potential transmission of animal viruses to patients and potentially the wider community. The guideline although not specifically directed towards the use of pigs as source animals, does place some emphasis on the use of this species. The minimum health status of the animals should be free of specified pathogens, however the document does accept the potential use of animals originally reared for food consumption. Cells from genetically modified animals should be characterised with respect to the transgene. Screening the source animals for infectious agents should cover, recognised animal pathogens (including endogenous agents), zoonotic agents and human pathogens. The harvested cells should also be tested and qualified with respect to a number of criteria, including microbiological safety, purity, identity etc. The guideline is not prescriptive on the types of tests but gives general opinions and view on the areas that should be investigated. This leaves the number and types of testing to the sponsor. |
| CPMP/BWP/2289/01 | Points To Consider On Development Of Live Attentuated Influenza Vaccines This document was adopted in Feb 2003 and comes into operation in Aug 2003. It details the requirements for live flu vaccines produced in eggs, and incorporates many of the requirements detailed in the European Pharmacopoeia (EP). |
| CPMP/BWP/3752/03 | The European Agency for the Evaluation of Medicinal Products (EMEA) Committee for Proprietary Medicinal Products (CPMP), EU published (30 July 2003) a Position Statement on West Nile Virus and Plasma-Derived Medicinal Products. This factual and advisory document was adopted at the July 2003 meeting of the Committee. The CPMP said that European companies using plasma from the US or Canada in their plasma-derived medicinal products should provide regulatory authorities with proof that their manufacturing process can inactivate or remove the West Nile Virus (WNV). There has been no systematic surveillance for the virus in Europe, CPMP said, but there have been sporadic outbreaks of the mosquito-borne disease in animals and humans, mainly in southern and central Europe. The recommendation in the CPMP position paper is based on evidence in the US that WNV could be transmitted by blood. The committee said, "Given the low levels and short period of viraemia in infected individuals, the data presented at the breakout session provided reassurance that the steps currently in place are adequate to assure viral safety of plasma-derived medicinal products with respect to WNV. It is recommended that Marketing Authorisation holders using US or Canadian sourced plasma in their plasma-derived medicinal products provide the concerned regulatory authorities with their product-specific assessment of the effectiveness of their manufacturing process for inactivation/removal of WNV." The committee noted that the position statement does not address the risk situation for whole blood and labile blood. |
| CPMP/BWP/1793/02 | The European Agency for the Evaluation of Medicinal Products (EMEA) Committee for Proprietary Medicinal Products (CPMP), EU published (30 July 2003) a Note for Guidance on the Use of Bovine Serum in the manufacture of Human Biological Medicinal Products. The guidance was adopted by CPMP at the July 2003 meeting. The date for coming into operation is 1 October 2003. The guidance covers bovine serum used in any part of the process for production of a human medicinal product, this includes serum which is used minimally, such as during establishment of a master cell bank. It is applicable to serum manufactured after the date of coming into operation. The responsibility of compliance lies with the marketing authorisation applicant but the testing may be done by the supplier, user or contract laboratory. The guidance covers all type of serum including FBS, newborn calf and donor bovine serum. Although not directly applicable to serum from other animal species such as horse, the principles defined within it are. There are requirements other than testing that have to be considered, including demonstration of compliance with the TSE/BSE guidance, i.e. Certificate of Suitability procedures. Specifically on the testing for adventitious agents, sterility and mycoplasma are to the EP, but it should be noted that only cultivatable mycoplasma testing is required. Viral contaminants includes a validated general in vitro test on two distinct cell lines, one of which should be bovine in origin. Specified viruses should be considered and their use depends on the ability of the general test to pick up the viruses and the current epidemiological situation on the country of origin. The viruses listed are bluetongue and related orboviruses; bovine adenovirus; bovine parvovirus; bovine respiratory syncitial virus, bovine viral diarrhoea virus; rabies virus and reovirus 3. If infectious virus is found the serum should not be used, with the exception of BVDV and BPyV provisos. It is acknowledged that BVDV cannot be completely avoided and that there is likely to be anti-BVDV antibodies in pooled serum that may mask the detection of virus. In this case the antibodies should be detected and their level taken into account for detection and quantitation of BVDV, and it should be shown that inactivated test serum does not have a significant (>2 logs) inhibitory effect on the growth of a reference BVDV strain when compared to reference serum. BpyV is also considered to be a common contaminant and the guidance suggests application of infectivity tests for BPyV and to investigate methods for inactivation/removal. Other emerging viruses should also be investigated. It is strongly recommended that inactivation of the serum should be done in accordance with the standard practices as detailed in other CPMP guidance. |
| CPMP/1100/02 | Note for guidance on development of vaccinia virus based vaccines against smallpox . The European Commission (EC) and CPMP published (1 July 2002) a note of Guidance on the development of vaccinia virus based vaccines against smallpox. This document is intended to provide advice regarding the manufacture of, and preclinical and clinical development programmes for, smallpox vaccines that are produced by means of growing vaccinia virus in tissue culture or in embryonated hens' eggs. The tissue culture system may comprise primary cultures, diploid cells or continuous cell lines. This Note of Guidance (NfG) is also intended to form the basis of assessments for regulatory authorities of the quality, safety and immunogenicity of smallpox vaccines that have been prepared by such methods. Thus, the NfG describes the data that would be required in order to support an application for Marketing Authorisation in the EU. It is also a useful reference for any vaccine to be developed for use in the EU, the majority of the reference documents are available from Regulatory. |
| CPMP/QWP/158/01 Revision and EMEA/CVMP/115/01 Revision | Revision of note for guidance on quality of water for pharmaceutical use The CPMP and CVMP published (5 June 2002) a revision note of guidance on the quality of water for pharmaceutical use. The document is intended to provide guidance to the industry on the pharmaceutical use of different grades of water in the manufacture of active pharmaceutical ingredients and medicinal products for human and veterinary use. |
| CPMP/BWP/337/02 | CPMP BWP Risk assessment on use of lactose prepared by using calf rennet The CPMP issued (6 June 2002) a public report from the Biotechnology Working Party (BWP) meeting, held on 11 to 13 February 2002. The BWP had been requested to conduct a risk and regulatory assessment on the use of lactose prepared by using calf rennet. In relation to the risk assessment, the BWP has considered the following relevant processing parameters or factors: - age of animals (including their feed); - tissue used for producing calf rennet; - the procedure used to procure the abomasum, and - the lactose processing steps involved (in relation to dilution and partitioning). Taking all these factors together, the BWP concludes that the BSE risk in finished pharmaceutical grade lactose can be excluded from the scope of the TSE Note for Guidance, which is currently being revised. |
| CPMP/BWP/3354/99 | Note for Guidance on the Production and Quality Control of Animal Immunoglobins and Immunosera for Human Use The CPMP published (29 July 2002) the adopted Note for Guidance on the Production and Quality Control of Animal Immunoglobins and Immunosera for Human Use, CPMP/BWP/3354/99. The document outlines the requirements for animal immunoglobulins/immunosera for therapeutic use in humans. The quality of animal immunoglobulins/immunosera should be considered on a case-by-case basis taking into account the individual character of each product, the clinical indication, and the availability of alternative products. |
| CPMP/3097/02 - Annex | Draft Note for Guidance on the comparability of medicinal products containing biotechnology-derived proteins as drug substance CPMP/3097/02 - Annex The CPMP published (1 August 2002) a draft Note for Guidance on the comparability of medicinal products containing biotechnology-derived proteins as drug substance. In this note for guidance on Comparability of Medicinal Products containing Biotechnology-derived Proteins as Drug Substance two situations are indicated in which comparability might become an issue: - when a change is introduced in the manufacturing process of a given product, - when a product is claimed to be similar to another one already marketed. The purpose of this document is to explore which non-clinical and clinical data will be required in these situations. |
| CPMP/BWP/764/02 | CPMP, Points to consider on the quality aspects of medicines containing active substances produced by transgenic plants - draft. The Committee for Proprietary Medicinal Products (CPMP), EU published (2 May 2002) a draft "Points to Consider" document on the quality aspects of medicinal products containing active substances produced by stable transgene expression in higher plants.The document addresses the quality attributes related to the production of medicines active substances made from transgenic plant technology. It also considers environmental issues affecting the medicinal products and their manufacturing processes in this particular technology field. The document is released for consultation only. |
| CPMP/BWP/1412/02 | Position statement on testing for SV40 in poliovirus vaccines The Committee for Proprietary Medicinal Products (CPMP), EU published (8 May 2002) a "position statement" document on testing for SV40 in poliovirus vaccines. The document recognises the several approaches that are used to detect and exclude SV40 (a polyoma virus) contamination from oral poliovirus vaccines as published by the World Health Organisation (WHO) and the European Pharmacopoeia (Ph Eur). |
| CPMP/BWP/1571/02 | Position statement on the quality of water used in the production of vaccines for parenteral use The Committee for Proprietary Medicinal Products (CPMP), EU published (8 May 2002) a "position statement" document on the quality of water used in the production of vaccines for parenteral use. The document provides recommendations on the quality of water to be used in the production of antigens used in the manufacturing process of vaccines. Three different qualities of water are considered: purified water (PW), highly purified water (HPW) and water for injection (WFI). Advice is offered on which quality of water should be used during the different stages of the manufacturing process. |
| CPMP/BWP/6622/02 | Concept paper on the development of a note for guidance on requirements for the evaluation of new adjuvants in vaccines The Committee for Proprietary Medicinal Products (CPMP), EU published (8 May 2002) a concept paper on the development of a note for guidance on requirements for the evaluation of new adjuvants in vaccines. The document recognises the limitations of current guidance and addresses issues of developing regulatory and scientific guidance for future studies on adjuvants in vaccines by focusing on the following: -Pharmaceutical & biological aspects: e.g. adjuvant(s) compatibility with antigenic components, proof of efficient adsorption of antigenic components), etc. -Pre-clinical safety aspects: e.g. local acute and chronic inflammation; hypersensitivity; anaphylaxis, etc. A list of new classes of emerging vaccine adjuvants is presented in the context of a recognised need for any new guidance to have provision for revision as scientific knowledge expands in this area. The deadline for comments is the end of July 2002. |
| EMEA/CVMP/556/02 | CVMP Public Statement on CPMP Public Statement on Lactose Prepared Using Calf Rennet and BSE The Committee for Veterinary Medicinal Products (CVMP), EU published (21 May 2002) a public statement on Lactose prepared using Calf Rennet: Risk Assessment in relationship to Bovine Spongiform Encephalopathies (BSE). Two points are clarified: - "The risk assessment applies only to pharmaceutical grade lactose prepared using calf rennet; - A full risk assessment would still be required for Lactose produced using any other materials of ruminant origin that fall within the scope of the Note for Guidance EMEA/410/01 Rev.1)." |
| CVMP/VICH/463/02 - CONSULTATION | EMEA releases VICH document on detection of mycoplasma for public comment The European Agency for the Evaluation of Medicinal Products (EMEA), EU published (21 May 2002) draft VICH guideline on Testing for the detection of mycoplasma contamination (VICH Topic GL34 - step 4). The document describes the test procedures to detect the presence of mycoplasma contamination. It also highlights the stages of manufacture where the test should be done.The document is released for consultation only. The deadline for comments is May 2003. |
| EMEA/CPMP/571/02 | TSE and Milk Derivatives - Risk on regulatory assessment of lactose prepared using calf rennet. EMEA published on1 March 2002 the public statement on "Lactose Prepared with Calf Rennet: Risk Assessment in Relationship to Bovine Spongiform Encephalopathies (BSE)". The scientific risk assessment performed by the Biotechnology Working Party (BWP) leads to the conclusion that BSE risk in pharmaceutical grade lactose is negligible. The same statement can be made for other products derived from whey such as lactulose, galactose and ethanol. |
| CPMP/BWP/2490/00 | CPMP Guidance on Cell Culture Inactivated Influenza Vaccines – Adopted The Committee for Proprietary Medicinal Products (CPMP), EU published (24 January 2002) a Note for Guidance on "Cell Culture Inactivated Influenza Vaccines" (CPMP/BWP/2490/00 Adopted). The document is an annex to the Note for Guidance on "Harmonisation of Requirements for Influenza Vaccines. It was adopted by the CPMP in January 2002. It will come into effect in August 2002. This adopted guideline has changed from the draft in a number of areas; they are mainly additional information and guidance. The adopted guideline now makes reference to the PhEur monographs for vaccines, highlights susceptibility to human pathogens, adding in EBV, HSV and CMV to list of pathogens to be considered, recommends evaluating the need for additional studies for standardisation and highlights the need for safety profiling in comparative trials. |
| CPMP/BWP/3207/00 | The CPMP published on 01 October 2001 the final version of the guidance titled ‘Note for Guidance on Comparability of Medicinal Products Containing Biotechnology-Derived Proteins as Drug Substance.’ This guideline addresses the issue of demonstration of comparability for medicinal products containing proteins derived from r-DNA and hybridoma techniques. This includes ‘generic’ biotech molecules. The final version does not differ greatly from the draft that has been available for some time. |
| CPMP/BWP/2053/01 draft – III/5272/94 rev 1 | CPMP – Control of starting materials for plasma derived medicinal products. CPMP published on 7 August 2001 a draft document titled ‘Contribution to Part S2.3 of the Structure of the Dossier for the Applications for Marketing Authorisation – Control of Starting Materials for the Production of Plasma-Derived Medicinal Products. (CPMP/BWP/2053/01 draft – III/5272/94 rev 1)’ The draft contains a further set of forms and instructions to be used in the event that a human plasma derived product is used in a medicinal product whether as an active substance or excipient. The final date for comments on this draft is December 2001 |
| EMEA Guidance New Notice to Applicants (Eudralex Vol 2B) | New format for marketing authorisation applications The Common Technical Document (CTD) format of the dossier was finalised by ICH late last year and has now been incorporated into the EU Notice To Applicants. Volume 2B is concerned with the presentation of the application dossier and was first published as a separate volume in 1998. It provides guidance for the compilation of dossiers for applications for European marketing authorisations and is applicable for the centralised procedure and national procedures, including mutual recognition. This latest update takes account of the international agreements on the structure and format of the CTD which was agreed in November 2000 within the International Conference on Harmonisation (ICH) framework. The CTD is an internationally agreed upon format for the preparation of a well structured presentation for applications to be submitted to regulatory authorities in the three ICH regions of Europe, US and Japan. It is intended to save time and resources and to facilitate regulatory review and communication. The CTD gives no information about the content of a dossier and does not indicate which studies and data are required for a successful approval. The format can be used from July 2001 and is expected to be mandatory from July 2003. |
| CPMP/BWP/41450/98 | CPMP published (11 June 2001) the adopted "Points to Consider" document on the manufacture and quality control of human somatic cell therapy medicinal products (CPMP/BWP/41450/98).
This document provides general principles to consider for the development and assessment of human somatic cell therapy products without prejudice to medical practice or national legislation, which may be applicable. The document was discussed within the Biotechnology Working Party (BWP) in May 1999. It was adopted by the CPMP in May 2001. It differs from the previous draft in the following aspects: GMP facilities for manufacture is now specified; the scope no longer excludes xenogeneic cells; cell type characterisation to include biological function; additional detail for autologous donor selection; additional recommendations for other materials and reagents used, which incorporates previous section on in vitro manipulation procedures; characterisation of cells in vivo no longer included. |
| CPMP/BWP/3088/99 | CPMP published the adopted ‘Notes for Guidance’ document on the quality, preclinical and clinical aspects of gene transfer medicinal products (CPMP/BWP/3088/99). It was adopted in April 2001 and comes into force in October 2001.
The majority of the document is the same as the draft with the following differences: now specifies a minimum of 3 successive batches should be fully characterised and any differences investigated; additional guidance on source of cells; states that GCP as laid down in ICH E6 should be followed; and includes in the safety testing for clinical trial materials that viral safety monitoring includes viral shedding monitoring. |
| EMEA/410/01 – Rev 1 | EMEA/410/01 Rev. 1 adopted 31 May 2001 on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products. Revised to introduce a footnote on the use of Specified Risk materials in medicinal products, and to reintroduce a footnote referring to Commission Decision 98/256/EC (on emergency measures to protect against BSE). The first footnote states that although medicinal products are excluded from the decision on Specified Risk Materials, they should not normally be used in the manufacture of medicinal products unless in exceptional and justified circumstances |
| EMEA/CPMP/BWP/476/01 | The EMEA published on 6 March 2001 a public statement about the risk of transmitting Bovine Spongiform Encephalopathies (BSE) infectious agent via the use of bovine material in or during the manufacture of vaccines. The document emphasises that existing regulatory controls and risk/benefit assessments undertaken by the EMEA, prior to the issue of marketing authorisations for vaccines, should ensure a remote risk of transmitting BSE infectious agent. |
| EMEA/CPMP/BWP/498/01 | The CPMP published on 6 March 2001 an explanatory note for medicinal products for human use on the scope of the guideline titled: "Joint CPMP/CVMP Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy agents via Human and Veterinary Medicinal Products". In addition to describing the scope of the guideline, the document addresses areas that may have presented difficulties in terms of their interpretation and application from a scientific viewpoint. In particular, the document confirms that materials derived from pigs, birds, or humans and non-human primates are excluded from the scope of the guideline. In addition Master Seeds or Cell Banks (MSs or MCBs) for already authorised products such as vaccines are outside the scope, however the origin and nature of the materials should be documented and a risk assessment performed. |
| CPMP/BWP/1143/00 | Tumourigenic cells of human origin The CPMP published (8 March 2001) a position statement from the Biotechnology Working Party (BWP)(CPMP/BWP/1143/00). The document comments on the use of and risk assessment for tumourigenic cells of human origin for the production of biological and biotechnological medicinal products. This position paper was adopted in February 2001. |
| CPMP/QWP/848/96 – EMEA/CVMP//598/99 | The CPMP and CVMP published (8 March 2001) the adopted version of the note for guidance on process validation. The document was originally prepared by the Quality Working Party (QWP). It assists applicant for marketing authorisation to evaluate the manufacturing process and/or the data that need to be generated to validate the process used for manufacturing finished product. This note for guidance was adopted by the CPMP in February 2001. The date for coming into operation is September 2001. |
| EMEA/CVMP/019/01 | CVMP, Position Paper on Risk of Transmission of Animal Spongiform Encephalopathy Agents The Committee for Veterinary Medicinal Products (CVMP), EU published (19 February 2001) their Position Paper on risk assessment of the use of starting materials of ruminant origin in veterinary medicinal products intended for use in ruminant species. The document describes the circumstances under which additional risk assessments should be carried out. It also details the factors that should be taken into account when minimising the risks of transmission of Transmissible Spongiform Encephalopathy (TSE) to ruminant species. |
| EMEA/CVMP/201/01 | CVMP, Position Paper on Risk Assessment of the Use of Starting Materials of Ruminant Origin. The Committee for Veterinary Medicinal Products (CVMP), EU published (19 February 2001) their Position Paper on the assessment of the risk of transmission of animal spongiform encephalopathy agents by master seed materials used in the production of veterinary vaccines. The document describes the factors that should be addressed when assessing the risk posed by established seed materials with regards to the transmission of animal spongiform encephalopathy agents. The document also comments on individual risk factors and the likelihood of their occurrences in relation to different vaccines |
Although care has been taken in the preparation of this web site BioReliance. cannot be held responsible for the accuracy of the information contained within the web site, nor for any consequence arising from such information. You are advised to seek additional advice when making decisions based on information you have obtained from this web site.