Marketing approval application

Under the centralized procedure, applications are accepted with regard to (a) products of biotechnology (b) NCEs (drugs in which the active ingredient is new). Biotech products are grouped as list A and NCEs as list B . Marketing approval application for biotech products must be considered under the centralized procedure, whereas NCEs can be considered under centralized or decentralized mechanisms. 

Consideration of the proposed indications for the candidate drug together with knowledge of its pharmacokinetics and metabolism in healthy volunteers will indicate whether specific studies in patients with impaired hepatic or renal function will be needed to be included in the Marketing Approval Application and NDA. Useful relevant guidelines are available on the FDA website and it is advisable to discuss proposals with the relevant regulatory authorities. The topic is considered in more detail in Chapter 5. 

Specifications evolve during this process to the point at which, in a marketing approval application, a formal specification can be set that encompasses all that has been learned about the drug substance and its formulations during development. 

PMA Pre-Market Approval Application (FDA) Pharmaceutical Manufacturers Association (now PhRMA) (equivalent to NDA for Class III Devices)... 

Code of Federal Regulations, Title 21, Food and Drugs, Part 314, Applications for FDA approval to market a new drug or antibiotic drug, Subpart B, 314.70 Supplements and other changes to an approved application. 

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. 

In 1993, a significant advance in simplifying the procedures relating to drug marketing authorization applications in the EU was made. At that time, the legal basis of a new drug approval system... 

Unlike the FDA, the EMEA itself does not directly undertake appraisals of drug dossiers submitted to support marketing authorization applications under the centralized procedure. Instead (as discussed in detail below), they forward the dossier to selected national EU regulatory bodies, who undertake the appraisal, and the EMEA makes a recommendation to approve (or not) the application based upon the national body s report. The overall role of the EMEA is thus to coordinate and manage the new system. The EMEA s annual budget is of the order of 120 million. The key objectives of the EMEA may be summarized as ... 

Detergent dispensing is, of course, another application area for electronics. The solutions offered so far, however, have not met with market approval. 

Dissolution tests are used nowadays in the pharmaceutical industry in a wide variety of applications to help identify which formulations will produce the best results in the clinic, to release products to the market, to verify batch-to-batch reproducibility, and to help identify whether changes made to formulations or their manufacturing procedure after marketing approval are likely to affect the performance in the clinic. Further, dissolution tests can sometimes be implemented to help determine whether a generic version of the medicine can be approved or not. 

The regulatory process is the filing of an IND for clinical trials. At the conclusion of clinical trials, the Sponsor files a Biological License Application (BLA) for marketing approval. The CBER evaluates a biologic in terms of risk versus benefits before approving it for marketing. 

Similar to the US requirements, there are two regulatory steps to go through before a drug is approved to be marketed in the European Union. These two steps are clinical trial application and marketing authorization application. There are 27 member states in the European Union (as of August 2007) clinical trial applications are approved at the member state level, whereas marketing authorization applications are approved at both the member state or centralized levels. 

The influence of ethnic factors on drug responses in clinical trials is important in two contexts. First, the regulatory application should contain data that is generated from subjects whose ethnic mix is in proportion to that in the population where the medicinal product will be used. Second, an applicant may wish that data generated in one country with one ethnic predominance should be used to gain marketing approval in another country where the ethnicity of the population is different. 

There are currently five clinical evaluation units within DSEB, each headed by a senior medical officer and supported by pharmacists. Applications are distributed among the five evaluation units based on the therapeutic area of the drug under evaluation. The DSEB contracts a number of external clinical evaluators who are specialist medical practitioners in the medical condition that the proposed new drug is intended to treat. External evaluators may also be contracted to evaluate the Module 4 data. The head of the clinical evaluation unit coordinates the evaluation and makes the final decision on marketing approval as a delegate under the Therapeutic Goods Act. 

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