Review 2001: The Future of European Pharmaceutical Legislation
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G 2002 Drug lnfornialion Association Inc.
REVIEW 2001: THE FUTURE OF EUROPEAN PHARMACEUTICAL LEGISLATION LOUISELAMB GMG BioBusinrss. London, United Kingdom
PAOLOM. BIFFIGNANDI Societi ltaliana Attivita Farmaceutiche, Torino. Italy
Following six years of use of the European procedures. Review 2001 sets out to propose changes to these systems. The prelirrrirra~remarks were recently published. They iniroduce changes that were agreed upon by the Europenn Commission in Ju1.v 2001, subject tofurther linguistic and legal verifications. These are currently working documents, not the final legislative proposals to be presented by the European Commission to the Europeun Parliurnent and the council f o r mdoption. These proposals are likely to be adopted by 2004. This nrticle focuses on the changes proposed f o r hiinrun medicinal products. with only a f e w remarks on veterinnry medicinul products, and on certain kev changes. These include changes to the Centralised Procedure. the removul of the need f o r renewal applications. the requirement f o r products to be placed on the nrurket within two years of marketing authorization. the updated structure of the European Agency f o r the E v ~ ~ u A tion of Medicinal Products, conrpassionute use f o r medicinal products, and the proposed Decentralised Procedure. Key Words: European drug legislation; Regulatory affairs; Review 200 1
INTRODUCTION THE CURRENT EUROPEAN pharmaceutical legislation (for the authorization and supervision of medicinal products for human and veterinary use) was laid down in 1993 and came into force on January 1, 1995. Its aims include: pooling the scientific expertise of Member States in order to ensure a high degree of protection for public health, ensuring the free movement of pharmaceutical products, and ensuring that European citizens have access to the new generation of medicines.
Reprint address: Paolo M. Biffignandi, Societb Italiana Attivita Farmaceutiche. Corso Re Umherto 44. 10128 Torino, Italy. (e-mail: pbiffignandi~siaf-home.com).
On the basis of the provisions in Article 7 1 of Regulation No 2309/93 (establishing the European Agency for the Evaluation of Medicinal Products [EMEA]) external consultants conducted an audit in 2000 on behalf of the European Commission to evaluate the agency’s procedures and operations. The audit analyzed the comments of various concerned parties (competent authorities of the Member States, pharmaceutical companies, doctors’ and pharmacists’ organizations, and consumer associations) and concluded with several crucial remarks. The centralized system, and to a lesser extent the mutual recognition system, have made a significant contribution toward a harmonized market in medicinal products. There was a strong de-
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sire to retain but improve both systems in parallel. However, neither the centralized system nor the Mutual Recognition Procedure currently meets the needs of manufacturers of generic
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