Marketing authorization

ADR reporting may be either voluntary or obligatory. Spontaneous reporting by health professionals is often favoured, since it is very difficult to make reporting compulsory. But in many countries, considerations of ethical responsibility and/or technical expediency have inclined governments to make reporting mandatory for the holders of marketing authorizations. 

The countries use similar means for disseminating information from the review. In Australia, Cypms, Estonia and Venezuela, ADR information and the results of report evaluation are published in bulletins which are distributed to physicians and pharmacists. In Tunisia, such information is disseminated at health professionals workshops. In Malaysia, review information is also sent to the reporters and the marketing authorization holders as information feedback. In every country, review information is forwarded to the DRA. Each of the countries also sends reports to the WHO Collaborating Centre for International Dmg Monitoring. 

Reporting by marketing authorization holder Mandatory Mandatory Voluntary Mandatory Mandatory Mandatory Mandatory y Mandatory Voluntary... 

In this chapter, the regulatory requirements relating to data on development pharmaceutics and process validation will be discussed. The discussion will be limited to Marketing Authorization Applications (MAAs) for the European Economic Area and many central and eastern European countries. 

II. LEGAL BASIS OF MARKETING AUTHORIZATIONS IN THE EUROPEAN ECONOMIC AREA (EEA)... 

A. Application Procedures by Which a Marketing Authorization May Be Obtained... 

There are three procedures by which pharmaceutical products may gain a marketing authorization in the EEA. These are the National, Mutual Recognition, and Centralized procedures. 

The basis for applications will follow the principles laid down in basic European level legislation for the pharmaceutical sector. This is more or less common regardless of the actual mechanism used to gain an approval. The basic requirements for pharmaceutical marketing authorization applications are laid down in Directive 65/65/EEC (as amended). There are no specific requirements for pharmaceutical development or process validation included in the text of that document. 

Three volumes of information on the format and content of applications for marketing authorization and relevant regulatory guidelines have been prepared by the Commission (Enterprise Directorate General) and published as the Notice to Applicants. These volumes do not have legal force, but applications that fail to follow their prescriptions can be returned to applicants as invalid. 

Readers may also be aware that under the auspices of the ICH a document is being developed on the organization of the Common Technical Document. It is intended that this will result in a common format (and, to at least some extent, content) of marketing authorization applications in the jurisdictions of those party to the ICH process (Japan, the EEA, and the United States). At the time of writing, a draft document had been circulated for comment. When adopted and implemented, this will result in a considerable amendment to the format and sequencing of information in a marketing authorization application. 

In the earliest development pharmaceutics guideline it was indicated that development pharmaceutics studies may be needed to support a marketing authorization application. Subsequent documents have made it clear that such data will be expected to form part of the application. 

The draft guidelines give considerable information on how an applicant can submit relevant data to request parametric release. However, since this is unlikely to be accepted until considerable manufacturing experience of the product concerned has been gained, it is probable that this will be submitted as a later variation application rather than in an initial marketing authorization application. 

B. Commission Guidance on the Format and Content of Applications for Marketing Authorization... 

The overall philosophy behind granting a marketing authorization for a new drug is broadly similar in the USA and Europe. There are, however, major differences in the systems by which these philosophies are implemented in the two regions. 

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