Masterstudiengang "Drug Regulatory Affairs"


Challenges For The Pharmaceutical Legislative Implementation In Terms Of An Accelerated Market Access After October 2005 ***

Dr. Tatyana Benisheva-Dimitrova (Abschlußjahr: 2006)

Language: English

The marketing authorisation procedures for medicines have been gradually developed since 1965 and are still subject to optimisation and changes to meet new requirements and raised challenges. The current system is based on three separate procedures for receiving a marketing authorisation for a medicinal product: centralised, decentralised, and national.
The Centralised Procedure (CP) is mandatory for certain medicinal products developed by means of biotechnological processes and for new active substances in specific therapeutic indications. Regulation (EEC) No 2309/93 which entered into force in 1995 introduced the Centralised Procedure and was subsequently revised by Community Regulation (EC) 726/2004, which has partly been in force since May 20, 2004 (Title IV), while the remaining titles only came into effect on 20 November 2005.
For those medicinal products not falling under the mandatory scope of the Centralised Procedure, the EU system provided the Mutual Recognition Procedure (MRP), which had been introduced on the basis of Council Directive 93/39. For situations where an applicant intends to market the medicinal product in one Member State (MS) only, there is still the option to apply for a solely National Marketing Authorisation in this Member State. Directive 2004/24/EC and Directive 2004/27/EC, which amend or change the existing Community Code - Directive 2001/83/EC, have come into effect as from October 30, 2005 and introduced the Simplified Procedure for herbal and homeopathic MPs and the new Decentralised Procedure.
The aim of this that study is to survey the EU pharmaceutical legislative frame of the intellectual protection, of the marketing authorisation procedures and arbitrations in the current legislation, Review 2005, with the previous Community law to estimate whether procedures for accelerated market access of medicinal product approvals are available.
The results of the comparative analyses provide many advantages that have been introduced in the new review 2005 versus former pharma legislation. The new legislation makes easier both innovative and generics products to access the European Market. It brings especially substantial improvements in the generics and innovative area in particular of introducing many new terms and issues: definition of generic, of reference medicinal products, of biosimilar.
Harmonisation of the 10-year market exclusivity period is introduced in the EU Pharma law. The new periods of the exclusivity provision will only be applied to reference medicinal products whose marketing authorisation applications are submitted after the new provision has come into force. The reality is that the generic industry will profit from the “eight-year provision” not earlier than 2013 because the last date for the directive transposition is October 2005. In real life, at least part of the two years of earlier generic submission before expiration of market exclusivity of the reference product will be used for the evaluation of the submitted generic dossier. However, this will still give the opportunity for an accelerated launch of generics.
Even the scope of the Community procedure is enlarged with many new diseases like acquired immune deficiency syndrome, cancer, diabetes, neurodegenerative disorders. Possibility for marketing authorisation of generic versions of a reference product authorised by the Centralised Procedure through the Mutual Recognition Procedure will be available. Biosimilar and orphan MPs are only in the scope of the Centralised Procedure in order the patients in all Member States to benefit from these products.
The legislative pharmaceutical documents, in force since autumn 2005, are focused on Centralised accelerated assessment procedures (217 days), which isby 60 days (28%) shorter than the normal current CP (277 days). Concerning the duration of the assessment in the CP, the current deadline of 210 days could be reduced up to 150 (22%) days in case of Accelerated Procedure. The period till the Commission Decision (CD) becomes 36 (12%) days shorter than in the previous legislation. Now the time for Commission Decision is absolutely fixed, 15 days, in contrast with the previous legislation, where that period of time was not limited and legislatively fixed.
Except the specific marketing authorisation of medicinal products on Exceptional circumstances in force in the previous Community law, new temporary marketing authorisation Conditional Authorisation and Compassionate use with incomplete dossiers with positive risk/benefit balance, based on early evidence and annual reassessment for a rapid availability of innovative medicines for patients, are already possible.
In the newly established Decentralised Procedure (DP) the applicant is again free to choose the EU Member State that will act as the Reference Member State (RMS). Harmonisation in both procedures DP/MRP, concerning Summary Product Characteristic (SmPC) and PIL is in force among all MSs parallel with the Assessment Report (AR). Now, the Decentralised Procedure (240 days) has advantagesto the previous MRP (420 days) not only with respect to the shorter period with 180 (42%) days in the Referent Member State (RMS) and Concern Member States (CMSs) phase but also in the arbitration process due to the efforts of the Co-ordination Group for Mutual Recognition and Decentralised Procedures ((CMD (h)) Group in case of reaching consensus in 60 days. The new updated MRP, where claims of “potential serious risk to public health” are raised, will also profit in the same way from the new activity of the established CMD (h) Group, which replaces the Mutual Recognition Facilitating Group (MRFG).
For the Simplified Registration Procedure, which is known as “traditional-use registration”, traditional use for 30 years should be demonstrated including at least 15 years in the Community. The new EMEA Herbal Medicinal Product Committee will be a key element in the new regulatory environment for herbal products in the EU and it may provide major clarifications from regulatory point of view through the establishment of monographs and lists for herbal medicinal product. The transitional period for herbal medicinal products till 2011 is also an opportunity to allow products existing on the market to continue to accumulate evidence of usage in the EU. Overall, by 2011 all herbal medicinal products will have to be licensed/registered in order to stay on the market.
In general, in Review 2005 particular attention is attributed to the implementation of provisions reinforcing the safety of medicines, accelerating the access of medicines to the EU market, and availability to the patients, respectively. Thanks to the network and the activities between the EMEA and more than 42 national competent authorities (NCAs) in the EU, the implementation of the amended legislation in late 2005 will be optimised in order to meet all new pharmaceutical challenges in the enlarged EU.
Pages: 68
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