Regulatory authorities License Application

Phase IV. post-licensing studies in the target population, with widening of entry criteria to broaden experience in clinical practice study objectives are typically surveillance for safety or further comparisons with other therapies. The results of such trials are more likely to be used for marketing purposes than in support of applications to regulatory authorities. 

In the licensing process, it is essential for each regulatory authority to recognize as equivalent those test procedures that have been harmonized and adopted as validated methods by the PDG. This concept is already included in the Japanese Guidelines for Preparation of Section B of the Documents Accompanying New Drug Applications as of September 1995 in its assertion that, The analytical procedures in the Japanese Pharmacopeia and other compendia and those which are accepted through international harmonization are considered to be validated methods. ... 

The manufacturer must be licensed by the regulatory authority in the country of manufacture of the product (also referred to as the country of origin or COO) to manufacture the product or the dosage form of the product. A copy of the manufacturer s licence issued less thcin 2 years ago and which has not expired is required to be submitted (section B5 of application form). 

Most of the work of the national regulatory authorities concern license variations, line extensions and license renewals. The application will follow the same approval procedure in which the original authorization was obtained. As many products currently licensed have been licensed through national procedures, before the mutual recognition or CP were available, many of the applications are still undergoing the national approval process in each MS separately. 

Regulatory documentation [IND, NDA, biological license application (BLA)] for submission to health authorities... 

As per the provisions of the Atomic Act, reconstruction or implementation of other changes in nuclear facilities that affect nuclear safety, radiation protection, emergency preparedness and security falls into the category of activities for which a permission (license) must be granted by the Czech Republic regulatory authority, i.e., the State Office for Nuclear Safety (SUJB). The Act also outlines the contents of the documentation that must be submitted to the SUJB in support of the application for such a license. The documentation shall include the following information ... 

A Preliminary safety analysis report is available and has been sent to the Regulatory authority, but no formal licensing application has been submitted yet. This means a qualification of 1.5 in the corresponding scale. 

Design and regulatory status 1995 - Basic design completed - Preliminary SAR available and sent to Regulatory Authority. No formal licensing application submitted yet - Development of the project started in 1984 - Preliminary Safety Report completed in 1994... 

Control systems and PLCs serving in safety related applications may be required in the future to be in conformance with the requirements laid down in lEC 61508. Conformance may be required by regulatory authorities before licenses are issued. 

The applications for national authorisations are submitted to the national competent authority which, in the United Kingdom, is the Licensing Authority (LA), whose functions are discharged by the Medicines and Healthcare products Regulatory Agency (MHRA, previously Medicines Control Agency, MCA) of the Department of Health. The LA/MHRA are advised by the CSM, a multidisciplinary scientific body consisting of clinical, preclinical and pharmaceutical members well known for their expertise in their respective fields. Lay members are also included. 

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