Masterstudiengang "Drug Regulatory Affairs"


Marketing Authorisation Procedures under the New Medicines Legislation – Impact on the Pharmaceutical Research Industry and Strategic Aspects ***

Dr. Marion Heinzkill (Abschlußjahr: 2005)

Language: Englisch

The current pharmaceutical legislation obliged the European Commission (EC) to report on the experience acquired as a result of the operation of the two marketing authorisation procedures within six years of the entry into force of the Regulation 2309/93/EC. Directive 2004/27/EC amending Directive 2001/83/EC and Regulation 726/2004/EC contain the final provisions of the Review of the pharmaceutical legislation with respect to medicinal products for human use. Necessary legislative amendments include changes to the marketing authorisation procedures, as well as to other aspects such as restructuring of the EMEA, data protection, labelling, validity on marketing authorisation (MA), pharmacovigilance, generic applications and Good Manufacturing Practice.
The major benefit of the changes goes in line with the major objectives of the “Review 2001”, namely to ensure a high level of public health protection for European Union (EU) citizens, to strengthen the European Single Market, to increase competitiveness and transparency and finally to be prepared for the EU enlargement.

The centralised procedure (CP) leads to a single marketing authorisation valid throughout the whole Community. It is granted in the form of a Commission Decision, which is based on a scientific evaluation by the committees created within the European Medicines Agency (EMEA). This procedure is now mandatory for biotechnology products (including generics), products for the treatment of AIDS, cancer, neurodegenerative disorders or diabetes, as well as designated orphan medicinal products.
The decision-making process has been improved to allow a faster conclusion of the post-evaluation phase. In particular to ensure a rapid access to innovative products a fast track procedure has been established within the CP. Further changes affecting the CP allow a conditional authorisation for treatments intended for life-threatening, chronic or debilitating conditions. In addition a framework to allow prescription on a compassionate use basis will be put in place.
For those medicinal products, not eligible for the centralised procedure or where the applicant chooses not to follow the centralised procedure, the NML provides a mutual recognition procedure (MRP) for products where a MA already has been granted in one or more Member States and a decentralised procedure (DCP) for products that have not been authorised in any MS before. If during the 90-day European phase no agreement could be reached, the matter of concern will be referred to the Co-ordination Group (CG; legalisation of the former MRFG). Within the CG discussion all the Member States concerned by the application shall use their best endeavours to come to an overall agreement on the issue. If they fail, the matter is referred to the EMEA where an arbitration (referral) procedure is followed. New for both procedures is that besides the SmPC, the Patient Information Leaflet as well as the primary and secondary labelling is part of the approval thus providing a harmonised labelling throughout the EU comparable to the CP. The DCP provides a consultation between all Member States involved before the first MA is issued and in contrast to the MRP introduces a clock-stop period within the first assessment phase mainly conducted by the RMS. In addition through the DCP the MA is obtained at the same time in all Member States involved.

In general the pharmaceutical research industry welcomes the provisions of the NML. However, the promised overall benefit needs to be proven in practice. Several concerns remain amongst others with respect to transparency of the CP, the decreasing involvement of the national Competent Authorities (CA), the ability of the national CA to comply with the timelines currently proposed for the MRP and DCP and the ability of the CA to initiate additional pharmacovigilance evaluations at any time. Further clarification is required with regard to the national implementation of the new legislation in particular for the provisions concerning labelling, data protection, renewal and “Sunset Clause”.

Many criteria need to be carefully considered by the applicant to define the most appropriate MA strategy except in those cases where the procedure is already predefined by the classification of the medicinal product. Advantages of the MRP/DCP include its high flexibility with regard to market selection, co-promotion/co-marketing activities, trademarks, and samples. Time to market for the first MA granted by the RMS (MRP only) as well as the transparency of the assessment process is an additional benefit. The CP is less flexible than the MRP/DCP in terms of trademarks, co-promotion/co-marketing and duplicate applications. However, a major benefit of the CP is the provision of new measures to achieve a fast market entry of the product.

Pages: 41 Annexes: 5

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