The US FDA has issued a draft guidance for industry for the self identification of generic drug facilities, sites, and organizations. The key objective of the guidance is to significantly improve global supply chain transparency by requiring owners of facilities producing generic drug products and active pharmaceutical ingredients (APIs). The regulatory authority is now awaiting comments from the industry by October end.

The guidance is intended to assist human generic drug facilities, on how the US drug regulator would implement an identification requirement contained in the Generic Drug User Fee Amendments of 2012 (Public 19 Law 112-144, Title III), referred to as GDUFA.

The regulatory authority has provided the type of generic facilities, sites, and organizations required for self-identification along with the details of information like technical standards used for electronically submitting the requested information; and the penalty for failing to disclose the details.

Further, the guidance also explains generally which types of generic facilities, sites, and organizations will be required to pay user fees.

GDUFA is designed to speed up the delivery of safe and effective generic drugs to the public and reduce costs to industry. It will also enhance the transparency of certain other sites and organizations that support the manufacture or approval of these products to electronically self-identify with FDA and update that information annually.

Self-identification is required for two purposes. One is to determine the location of the facilities required to pay user fees and the other is self-identification to promote global supply chain transparency. The information provided through self-identification will enable quick, accurate and reliable surveillance of generic drugs and facilitate inspections and compliance, stated the regulatory authority.

Most facilities that self-identification will be required to pay an annual facility user fee are those facilities manufacturing or intending to manufacture, API of human generic drugs, finished dosage form (FDF) human generic drugs. But the sites that undergo self identification will not be required to pay the annual facility user fee. These include sites and organizations that solely manufacture positron emission tomography (PET) drugs; clinical bioequivalence or bioavailability study sites, in vitro bioequivalence testing or bioanalytical testing sites; API/FDF analytical testing sites; and repackagers. Once the self-identification process has been completed, FDA will determine facility fees and publish the amounts in the Federal Register.

FDA is also establishing a new system for the electronic self-identification of generic industry facilities, sites, and organizations. Therefore, entities that are required to register and list under section 510 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act, and those being required to self-identify under GDUFA, will be required to submit information separately to the respective systems. Each system will populate its own database to meet unique requirements and deadlines. The new GDUFA system will use the same platform and technical standards already familiar to manufacturers required to register and list, according to US FDA.

“India is a leading generic manufacturer which is eyeing to augment its global presence. With this self identification guideline, the industry will automatically be able to prove its excellence in production and traceability of raw materials. This would automatically create a sense of responsibility to adhere to quality systems right through the entire manufacture to marketing process,” said Jatish N Seth, vice chairman, Confederation of Indian Pharmaceutical Industry (CIPI), member Karnataka Drugs and Pharmaceutical Association (KDPMA) and director, Srushti Pharmaceuticals.