News and updates on pharmaceuticals
Pharmaceuticals Archives - 2000
Revised version of the draft Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another. (available for comments until 12 March 2001)
DG Enterprises releases a Guideline on the categorisation of New Applications (NA) versus Variations Applications (V) prepared by the Notice to Applicants Working Party and after consultation of interested parties.
This Guideline is part of the "Notice to applicants" Volume 2C - Regulatory Guidelines - of "The Rules governing Medicinal Products in the European Union".
On the 14 December 2000, the Council has adopted (qualified majority) the Directive as amended by the European Parliament (12 December 2000), on the approximation of regulatory, legislative and administrative provisions in the Member States covering Good Clinical Practice in the conduct of clinical trials for medicinal products for human use.
The final text will be published on this site as soon as it will be officially released.
Maximum Residue Limits of veterinary medicinal products in foodstuffs of animal origin
CONSOLIDATED VERSION of the Annexes I to IV of Council Regulation n"‑2377/90 Updated on 01.12.2000
Global Competitiveness in Pharmaceuticals, A European Perspective
Report Prepared for the Directorate General Enterprise of the European Commission by Alfonso Gambardella, Luigi Orsenigo and Fabio Pammolli
This report does not reflect the view of the European Commission
DRAFT Summary record of the 50th meeting of the Pharmaceutical Committee (21-22 September 2000)
Continuation of PERF Activities
The PERF II programme, initially scheduled to commence in November 2000 has been temporarily delayed. The programme, which will focus on Implementation of the 'acquis communautaire' (workshops on products on the market, borderline issues and phasing-in of products and procedures; review of legislation - input in the context of preparing the future accession); Pharmacovigilance; GMP (harmonisation of procedures; joint inspections); and Inter Agency Training (joint activities aimed at the exchange of scientific information and staff; attendance at EU regulatory Working Party meetings with specific sessions for participating PHARE country delegates dealing with the background to issues of interest; case studies) is now expected to commence in the first half of 2001.
Report on the "Evaluation of the operation of Community procedures for the authorisation of medicinal products", carried out on behalf of the European Commission by Cameron McKenna and Andersen Consulting.
Amended proposal for a European Parliament and Council Directive on the Community code relating to veterinary medicinal products
The Commission has adopted on 23rd September 2000 an amended proposal for a European Parliament and Council Directive on the Community code relating to veterinary medicinal products [COM (2000) 657 final]. This amended proposal includes the legislative modifications introduced since the adoption of the initial proposal [COM (1999) 213 final], i.e. Commission Directives 1999/104/EC and 2000/37/EC and Council Decision 1999/468/EC.
Updating the "Notice to Applicants : Veterinary Medicinal Products" Volume 6
Volume 6A Procedure for marketing authorisation
- Guideline on the processing of renewals in the mutual recognition procedure for veterinary medicinal products
Volume 6B Presentation and content of the dossier
- Major revision of the guideline on preparation of Summary of Product Characteristics SPC - Pharmaceuticals for veterinary medicinal products (This revised guideline will come into operation in January 2001 )
- Major revision of the guideline on preparation of Summary of Product Characteristics SPC - Immunologicals for veterinary medicinal products (This revised guideline will come into operation in January 2001 )
Following changes to the Committee for Orphan Medicinal Products an updated list is provided
Press release from ICH Steering Committee and Expert Working Group meetings, San Diego, 9th- 11th November 2000
TSE and medicinal products containing derivatives of milk, wool and hair
Following the recent revision of the Note for Guidance on "Minimising the risk of transmission of animal spongiform encephalopathy agents via medicinal products" (Revision of September 2000, CPMP/BWP/1230/98-rev.1) available on the EMEA website as of 31/10/2000, milk, wool and hair derivatives are excluded from the scope of the Note for Guidance provided that certain sourcing criteria are met for the milk, hair and wool.
For marketing authorisation applications, the applicant should mention that the milk derivative is "derived from milk sourced, from healthy animals in the same conditions as milk collected for human consumption" or for the wool and hair derivatives that "the wool and hair are sourced from live animals". In these circumstances, no additional documentation needs to be submitted in relation to TSE for these materials. Marketing authorisation holders of already authorised medicinal products do not need to provide any documentation in relation to those derivatives provided that the milk, hair and wool are sourced so that they are excluded from the scope of the above-mentioned Note for Guidance.
Updating the "Notice to applicants" Volume 2A Chapter 2 "Mutual Recognition"
The updated version released on September 2000 (Final Revision 0) has been slightly amended in order to clarify the Scope (2.3 Exclusions) and to update the Numbering System (5. Numbering System for the Procedures for Mutual Recognition). The new version is Final Revision 1 (October 2000).
The Committee for Orphan Medicinal Products Following changes to the Committee an updated list of members is provided.
New electronic template for ICH Step 2 Document draft ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
On 27/7/2000 a draft ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients was released for public consultation. In order to facilitate the submission and review of comments on this draft guide, a new electronic template for collecting comments is now available . Electronic submission of comments is encouraged, since it is anticipated that widespread use of this method will increase the effectiveness of the guidance development process. This document will become an annex to Volume 4 of the Rules Governing Medicinal Products in the European Union.
DG Enterprises releases the synopsis of interim report prepared by the consultant CMS Cameron Mc Kenna and Andersen Consulting on the evaluation of the operation of Community procedures for the authorisation of medicinal products.
8th August 2000 Commission designates first three Orphan Medicinal Products
Following the entry into force of the regulation on Orphan Medicinal Products, the Commission, on 8th August 2000, adopted the first three Community decisions designating potential new compounds as Orphan medicinal products. These medicinal products have now been entered into the newly created Community Register for Orphan medicinal products. It should however be noted that the safety, efficacy and quality of these products have not yet been assessed through the Community marketing authorisation procedures and therefore they cannot at this time be marketed in the European Community.
EudraLex - Volume 2C - Regulatory Guidelines
- Guideline on the processing of renewals in the mutual recognition procedure
- Application form and guidance notes for the completion of the application form
Prolongation of transitional period in the Canadian/EC MRA on GMP
The terms of the sectoral annex on Good Manufacturing Practice (GMP) of the agreement on mutual recognition between the European Community and Canada foresaw a transition period which was expected to last 18 months during which time the equivalence of the GMP systems of the EC and Canada would be evaluated. In May 2000, a provisional date for completion was set as 15th July 2000. Although the majority of this work has been completed, there are still some outstanding issues that need to be clarified. It is therefore, proposed that the transition period be prolonged. The operational period will not begin on 15th July as previously anticipated.
EFPIA Annual meeting 2000 - Mr Prodi's speech
Speaking at the annual meeting of EFPIA (the European Federation of Pharmaceutical Industry Associations), the President of the Commission, Mr Prodi, addressed a number of the forthcoming challenges, including the prospects for the forthcoming review of the European pharmaceutical legislation and the need to find a common cause and genuine European solutions in addressing the economic challenges in the pharmaceutical sector.
Competent authorities in the field of cosmetics
According to Article 7a(5) of Council Directive 76/768/EEC, the Member States shall designate the competent authorities referred to in paragraphs 1 and 4 of Article 7a and the Commission shall publish the list of the national competent authorities in the Official Journal of the European Communities. This list of national competent authorities in the cosmetic sector is updated every year. The last version was published in OJ C 36 of 10.2.1999, pages 10 to 12.
Model Declaration of compliance with the annex to Directive 75/318/EEC as amended by Directive 1999/82/EEC relating to the application of the Note for Guidance on "Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products!".
Following the Pharmaceutical Committee, the Notice to Applicants Working Party and the last Mutual Recognition Facilitation Group and in order to facilitate the examination of the documentation submitted for the demonstration of the compliance with the requirements stated in the above mentioned Note for Guidance, a set of documents are presented: - a model declaration of compliance with the annex to Directive 75/318/EEC as amended by Directive 1999/82/EEC relating to TSE accompanied by annexes specific to the nature of starting materials used; - a background note giving some further explanations.
Model Declaration .pdf - Word format
Annexes .pdf - Word format
Commission nominates members of the Committee for Orphan Medicinal Products.
The recently adopted regulation on Orphan Medicinal Products creates a new Committee, the Committee for Orphan Medicinal Products, responsible for providing opinions on whether or not a new medicinal product should be designated as an Orphan Medicinal Product. Designation allows the medicinal product concerned access to a series of incentives including market exclusivity, fee waivers and assistance with the protocols for clinical trial investigations. This Committee marks an important step in the increasing co-operation between regulatory authorities and patients, being the first European Scientific Committee to have representatives from patient organisations as full members. Based on an internal selection procedure the Committee has nominated the following members to represent patient organisations, Yann Le Cam, Mois!"s Abascal Alonso, representing the European Association for Orphan Diseases, Eurordis and Alastair Kent representing the European Alliance of Genetic Support Groups. The Commission also nominated Professor Jean-Michel Alexandre, Dr. Mary Teeling, current president and vice president of the CPMP and Dr. Gianmartino Benzi who is on the management board of the EMEA to facilitate close liaison and interaction with the work of the EMEA.The list of members from the EU Member States is provided.
A draft text of Annex 17 Parametric Release to the EU Guide to Good Manufacturing Practice was released for consultation on the 7 April 2000. The proposed deadline for comments is September 2000.
Annex 14 Manufacture of medicinal products derived from human blood or plasma to the EU Guide to Good Manufacturing Practice was adopted at the Ad-hoc meeting of the GMP Inspection services on the 11 February 2000. It is expected to come into operation on the 1 September 2000
A draft text of Annex 6 Manufacture of medicinal gases to the EU Guide to Good Manufacturing Practice was released for industry consultation on the 23 March 2000. The Proposed deadline for comments is the 31 August 2000.
Implementation of the amendment to the Annex of Council Directive 75/318/EEC.CPMP Briefing Document
CPMP Briefing Document concerning the implementation of the amendment to the Annex of Council Directive 75/318/EEC: demonstration of compliance with the CPMP-TSE guideline