The new Pharmaceutical Registration System in the EU

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1 ❹ The new Pharmaceutical Registration System in the EU M.C. Gouy Consulting GmbH Buchleitengasse 27 A-1180 WIEN AUSTRIA Tel: Fax: Homepage: 1

2 The new approach Since January 1, 1998 all registration applications within the European Community are treated according to the same procedures. This is a tremendous improvement over the previous situation which necessitated a negotiation with up to 12 different regulatory bodies. Whereas it allows faster and more transparent registration procedures, this new system has also its pitfalls and confronts the pharmaceutical companies with new types of decisions. Centralized procedure The centralized procedure requires a submission to the European agency. The procedure lasts about 300 days and results if positive in one single Marketing Authorization (MA) valid for all members states. It is mandatory for : Recombinant DNA technology, controlled expression of genes and monoclonal antibody methods. It is accepted in the case of : innovative medicinal products, new blood or plasma derivatives, entirely new indications, new innovative delivery systems or manufacturing processes. Decentralized procedure This procedure is also called "Mutual Recognition Procedure" and starts with the registration of the preparation in one member state called "Reference Member State" (RMS). This first step can take up to 300 days. The RMS is then responsible for initiating and carrying through the recognition process based on its assessment report. The ensuing recognition process can take a minimum of 90 days if there is no serious objections or another 120 days until a final opinion is delivered by the European Commission. National procedure It is to be used if the product is to be launched in one EU country only. Please note that parallel national submissions are not allowed. Do not think that this might be a quick way to introduce a poorly documented product as the local authority shall most likely apply the same decision criterions as the other member states. Principle of renewals Market Authorizations are valid for 5 years only and should be reviewed accordingly. Please note that this rule applies also to products authorized before the new system came into effect. As a consequence, numerous pharmaceutical companies shall run into difficulties trying to renew MAs for old and poorly documented substances. The relevant European Authorities The Agency responsible for the assessment of pharmaceuticals in the EU is the EMEA ( European Agency for the Evaluation of Medicinal Products). It is composed of one committee specialized for human pharmaceuticals and one for veterinary medicine. The CPMP (Committee for Proprietary Medicinal Products) handles all issues related to preparations for human use. 2

3 Competition between national registration authorities: A matter of survival It is clear that numerous member states see the development of a common registration system as an opportunity to drastically cut the size and ensuing costs of their local regulatory bodies. For most of these administrations, becoming RMS is therefore a question of survival. While some are clearly accepting the fait accompli and discourage ( under political pressure) the pharmaceutical companies from using them as RMS ( This is the case of Austria) some others position themselves ( UK, Holland, Sweden...) as reliable, professional and fast RMS. Choice of the Rapporteur country This is probably the most important decision you shall have to make during the registration procedure. You will notice that even if they have to accept your application some local authorities shall show some reluctance; This will be due to numerous fa c- tors: They will be overworked, understaffed or simply not comfortable with reviewing and defending your product in front of their peers. Some others on the contrary shall be overly eager to represent your product as this shall be one of the few ways to justify their existence. Be careful and check their track record as RMS very carefully. How to go about it? If your own regulatory department is not entirely familiar with the new EU system, take a local consultant, it will be worth the additional expenses. Take enough time deciding which local authority should lead the process pondering elements like reputation, experience, willingness, language etc Choose your consultant based of his intimate knowledge of the local authority you shall use as a Reference Member State. Ensure early on a very good personal contact with your Reference Member State as it shall determine the quality and commitment of their representation of your product with the CPMP. 3

4 What you have to think of... Make sure that you choose the right Reference Member State The choice of the right Reference Member State is crucial in the process. While many local regulatory bodies might be happy to help you, they might not have the clout or the experience ( or the resources...) to carry through the Mutual Recognition Process. Some others might be very knowledgeable but might not want to defend your product in front of their peers. Depending on the quality of your registration dossier and on your subsequent introduction strategy one RMS might be better than the other. A RMS might have already experience with the type of product you want to register. Always check their track record...make sure that your organisation can converse with the RMS and do not under-estimate the importance of a common language. Mistakes with disastrous consequences Make sure that your dossier is perfect since a refusal during mutual recognition shall have disastrous consequences. You shall not have the time to improve the dossier along the way as it was usually the case in the past. A EU registration might be faster to obtain than a FDA registration but it might not be easier. You should not assume that because the FDA has approved your product the EU will automatically do the same. There might even be a tendency in Europe to want to prove the FDA wrong! Get assistance from experts and make sure they know the relevant authorities personally. During a MRP the Authority of the RMS become your partner and have to convince their colleague about the qualities of your preparation. Do not let them down by not supplying information as they will loose their face and reputation within the EU. A high level of collaboration leads to better results and is only possible if your regulatory experts know the rapporteurs and assessors personally. A Marketing Authorization is not a reimbursement Once again we attract your attention to the fact that obtaining a Marketing Authorization is very often only the first step towards a launch in Europe. As already explained, the price of your preparation shall have to be negotiated separately with the local authorities. 4

5 Other similar brochures ❶ Too late for an entry in the Austrian Pharmaceuticals market? ❷ Starting Pharmaceuticals activities in Europe: Potential and Hurdles ❸ Optimal launch sequence for Pharmaceuticals within the EU Dieses Dokument ist urheberrechtlich geschützt. Alle Rechte der Verbreitung auch durch fotomechanische Wiedergabe, auszugsweisen Nachdruck oder Einspeicherung und Rückgewinnung in Datenverarbeitungsanlagen aller Art, sind vorbehalten M.C.Gouy Consulting GmbH Bankverbindung: Creditanstalt Filiale Nußdorf BLZ Kto.-Nr /00 Firmenbuch Wien: FN s Stammkapital: Geschäftsführer: M. Gouy Reg2000e 22. Mai