Formulation, Marketing Authorisation applications

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. 

An approach that tries to solve the problem more at the source is the so-called green pharmacy. In order to stimulate the development of more easily degradable medicines, both for human as well as for veterinary medicines, European guidelines are formulated. At the application stage to get a marketing authorisation the manufacturer has to give information about the effects of the medicine on the environment as well as an evaluation of those effects and measurements which have to be taken to prevent or reduce these effects [33-35]. When veterinary products are concerned, authorities can even deny the registration if the environmental risk is considered too big. Market authorisation can... 

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