Manufacturing authorisations , regulatory

It should be noted that all technical data submitted in support of marketing authorisations remain confidential between the applicant and the regulatory authorities. In situations where the manufacturer of a drug substance is a different commercial entity to the applicant seeking approval of a drug product incorporating... 

The Summary of Product Characteristics (SPC) for a medicinal product reflects the information in the marketing authorisation of the product. It is prepared by the manufacturer and is intended for health professionals. Updates are necessary to reflect any approved changes by the regulatory body in the marketing authorisation. 

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. 

Once included in Annex XIV, the manufacturers, importers, and/or downstream users of the affected substance must request authorisation. The application is directly submitted to ECHA, which forwards the dossier to its Committee for Risk Assessment (CRA) and its Committee for Socio-Economic Analysis (CSEA) to produce a draft opinion within 10 months of submission. Applicants and interested third parties receive an opportunity to comment on the draft, whereafter the now finalised opinion is forwarded to the Commission, the Member States, and the applicant. The Commission then decides on the authorisation request following the regulatory committee procedure,27 which gives the Council veto power, but only in the rare instances where it can muster a qualified majority against the Commission measure.28... 

Effectiveness As the subsequent issuing authorisations will depend on the provision of data to demonstrate that a substance use is adequately controlled, authorisation under REACH can be considered to be effective. For substances that may not meet the adequate control criteria - i.e., VPVB, PBT, non-threshold CMR or endocrine disruptors - but serve critical purposes to manufacturing or product use that might enable them to be authorised, effectiveness of stringent regulatory control would need to be demonstrated based on monitoring schemes. 

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. 

Where a manufacturer resides outside the EEA and there is no authorised representative, the importer assumes regulatory responsibility. If the importer is not established in the EEA, any other person resident in the EEA who places an apparatus on the market assumes the obligations of the direetive(s). 

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