Marketing authorisation regulatory controls

A ban on the production, marketing or use of a chemical offers the most stringent type of regulatory control. Prohibition provides clear-cut cases for product liability and enforcement, thereby minimising exposures resulting from poor regulatory compliance or irresponsible chemical use. Product or process35 bans can be in the form of restrictions or authorisations. Restrictions allow all uses of a chemical with the exception of those decided on a case-by-case basis. Under authorisation systems, all uses of a chemical are banned unless exempted. 

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. 

The confidence in the efficacy and safety of a medicine by a consumer (patient), the latter represented by inspection or regulatory agencies, is based partly on the warranty by the producer and further on requirements laid down in pharmacopoeias and other documents such as the marketing authorisation. The correct interpretation of the results of this system, called statistical quality control [2] or SQC is crucial to understand the character of the guarantee, when provided or asked for. In Sect. 20.4.3 the significance of this system will be discussed more in depth. 

After a product has been authorised, the regulatory system operates to keep the quality, safety and efficacy of that product under review and to control the way in which it is manufactured, marketed and distributed. The pharmaceutical legislation in Europe has recently been consolidated and, pursuant to Commission consultation and review, amended. The majority of the amendments are due to come into effect in November 2005. What follows, reflects the state of legislation as at close of 2004. 

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