Marketing authorisation evaluation process

The previous chapters examined the process for the development and authorisation of a drug product containing a ne v active ingredient for human use. This represents the most arduous path to market for any medicinal product. This chapter proceeds to examine the process of bringing a veterinary medicinal product to market. While the process shares most of the principles that apply to human drugs, there are some additional features that are unique to veterinary products. These include methods of use and the requirement to evaluate vithdra val periods and maximum residue limits in food-producing species. 

For applications to be processed via the centralised procedure, the CHMP appoints one of its members to act as rapporteur for the coordination of the evaluation of an application for a marketing authorisation. The CHMP may, and usually does, also appoint a second member to act as co-rapporteur. For line extensions, the CHMP will decide on the need for appointment of a corapporteur on a case-by-case basis. All members have an equal opportunity to act as the rapporteur or co-rapporteur, and therefore the CHMP members are invited to express their preference regarding rapporteurships in writing in advance of the meeting at which rapporteurs are appointed. Rapporteurs are usually appointed at every other meeting to facilitate the decision making process as regards (co)-rapporteurships. 

Once the clinical and safely evaluation studies for a new medicinal product have shown it to be safe, effective and of acceptable quality, the pharmaceutical company will usually want to submit a Marketing Authorisation Application (MAA) or New Drug Application (NDA) to the regulatory authorities. The chemistry, manufacturing and controls (CMC) section will form a major part of the application. For an MAA in Europe, a development pharmaceutics section is required to describe how the product was developed, and to explain the rationale for the selection of the formulation, pack, manufacturing process and specifications. Also required for Europe are expert reports for each of the pharmaceutical, safety and clinical parts of the application. These have to be written by experienced scientists nominated by the pharmaceutical company who have to critically appraise the development programme for the product. The pharmaceutical expert must acknowledge the acceptability of the CMC part of the application. 

Cefic claims that polymeric materials, reaction intermediates and substances used for R D should not be subject to the REACH evaluation and authorisation process being proposed by the European Commission in its White Paper on future chemicals policy, it is briefly reported. On specific issues, Cefic wants a risk-based approach to chemicals assessment and regulation realistic deadlines for the REACH process and exemption from REACH of finished articles, so that it applies only to substances marketed as substances or as constituents of a preparation. 

---