Applications for Market Approval

Registration dossiers should not be written and collected at the end of the development. The development process should start with an 

US authorities actively and officially encourage early and direct contact and discussion about trial protocols and general development strategies. Authorities in many other countries foster a more authoritarian attitude. They tend to discourage direct contacts and avoid to commit themselves by giving advice. In some cases responses will only be given after the full application has been recieved. 

A registration application is initially examined for completeness and compliance with the formal requirements, before the technical and scientific examination by specialized groups commences. The first official response from an authority may be a notification of the deficiencies of the dossier. Partly the objections may address only formal faults, other problems may be clarified by reference to the existing data, in other cases additional studies may have to be conducted to provide the required information. 

The review procedure can last anywhere between a few months and several years. An important factor determining the duration of this process is of course the quality of the data and the dossier. But there are also considerable differences between different authorities and countries dealing with the same application. 

Vaccines and similar products are often registered by specialized and smaller authorities which seem to have less complex ways of reaching a 

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APPLICATION FOR MARKETING AUTHORIZATION shall mean (a) in the United States a new drug application filed with the FDA pursuant to 21 U.S.C. Section 357 and 21 C.F.R. Section 314 ( NDA ) with respect to the Product and (b) in any country other than the United States, an equivalent application or set of applications for marketing approval comparable to an NDA necessary to make and sell Product commercially in such country. 

Expected to be completed before application for marketing approval (not needed prior to conduct of large-scale clinical trials unless cause for concern)... 

The definitions for quality, safety and efficacy vary between product groups, countries, authorities and between people within authorities. In fact, there are no exact definitions at all. There are directives, guidelines and recommendations describing what must or should be done and which data should be provided, but the application for marketing approval is judged on relative criteria. 

Application for marketing approval, using either the centralized or decentralized procedure, has to be accompanied by three expert reports, which... 

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

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, 314.50 Content and format of an application. 

Applications for FDA Approval to Market a New Drug or an Antiobiotic Drug, Content and format of an Application, CFR, Title 21, Volume 5, Part 314, Section 314.50 (1998). 

One additional strategic issue must be recognized in drug development. Submission of data to support the use of a medicine response test must be coordinated with the submission of the application for marketing of the medicine. In the U.S., both centers are under the umbrella of the FDA, but this is not necessarily true in all countries. The timing of these submissions is critical to ensure that the test will be available at the time of the approval of the drug. Furthermore, as mentioned above, for maximum efficiency in the approval of subsequent test improvements, DNA samples of patients whose data support the claims for the medicine response test need to be maintained according to GLP. 

A great majority of botanical sponsors have taken advantage of the pre-IND consultation service provided by FDA. As a result, most IND applications were successful with initial submission and few (less than 20) were placed on clinical hold for safety concerns. However, despite the early success, many development programs and research projects have subsequently been suspended for various reasons. As of the above-mentioned cutoff date (April 30, 2004), nearly two-thirds (66%) of INDs still remain active (have not been placed on clinical hold, inactivated by FDA, or withdrawn by sponsor for lack of activities). To date, there have been no submissions of NDAs to FDA for marketing approval of botanical prescription drugs. 

CFR, Part 314—Applications for FDA Approval to Market a New Drug or an Antibiotic Drug [15]. 

U.S. Department of Health and Human Services, Food and Drug Administration, 21 CFR 312, Food and Drugs, Applications for FDA Approval to Market a New Drug, Subpart C FDA Action on Applications. 

The results of the preclinical and clinical trials and all manufacturing, chemistry, quality control, and test methods data are submitted to FDA in the form of a new drug application (NDA) or a biologies license application (BLA) for marketing approval. 

PART 314 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG OR AN ANTIBIOTIC DRUG... 

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