Approval process of Generic drugs
Having won awards for its equivalent grade of efficacy and safety, generic drugs now are indispensable part of millions of lives. Streamlining human health at large, generic pills cover up nearly 50 percent of brand products available in the market. These bioequivalent generic prescriptions endow consumers with the same safety and efficiency as their brand counterparts.
But to live up to the users' high expectations, generic drugs have to comply with a number of strict norms outlined by the regional agencies regulating a multitude of medical, cosmetic and food products. Generic prescriptions must be therapeutically equivalent to their contenders not only in active ingredients' composition but also in several allied aspects including dosage form, route of administration, standards of quality, clinical impact and the quantity of drug absorbed over a specific period of time.
The regional agencies make constant efforts to ensure that the approval process for generic drugs is as rigorous and scrupulous as it is for the brand drugs. When a generic drug becomes triumphant in attaining the regional agency's approval, it implies that a generic drug is not only bioequivalent to its brand counterpart in relation to research and clinical studies but also in the context of safety and efficiency.
In order to manufacture an equivalent to a brand pharmaceutical product, as mentioned above, a generic drugs pharmacy first has to prepare a product having same active ingredients, strength, and route of administration as the brand name drug product. Only then it can forward an Abbreviated New Drug Application (ANDA) to concerned agency for approval. But generic drugs pharmacy can submit ANDA only when the market exclusivity over the primary manufacturer's product runs out. If you are wondering why the application is named as "abbreviated", it is simply because of non-execution of animal or human studies while the fabrication of generic drugs. The generic drugs pharmacy does not execute animal and human studies to gather data on the safety and efficacy of its product. They often use data furnished by the brand drug's manufacturer on the safety and efficacy of its product. They are only asked to validate that their generic medicines are chemically identical to the branded drugs.
Four stages of approval process
An ANDA undergoes four stages to get approved by the regulatory agency. The four phases include bioequivalence review, chemistry/microbiology review, labeling review, and pre-approval inspection. But prior to these four reviews, a preliminary review is also conducted by the concerned organization upon the application's receipt to ensure comprehensiveness and adequacy of every category. If the application is not found acceptable during the preliminary review, the applicant is informed about the same in written. And in case of acceptability, the application is forwarded for reviews after informing the generic drugs pharmacy about the suitability of its application.
1. Bioequivalence review
A bioequivalence review is carried out to ensure that the projected generic drug is "bioequivalent" to the brand drug indexed in the reference list. To be bioequivalent, generic pills are required to utilize the same time duration taken by the brand drugs to be available to the body. Besides, generic drugs pharmacies also have to ensure that the amount of the medicine assimilated by the body is under accepted limit when weighed against brand name product. As far as the authentication of bioequivalence is related, it is performed with the help of comparative dissolution studies executed in laboratories or by analyzing data gathered from tests carried out in fit human volunteers.
2. Chemistry/ Microbiology Review
The prime objective behind the execution of this review is to ensure that generic prescription is formulated under state-of-the art and controlled conditions. For this, regulatory agency reviews raw material, manufacturing procedure, containers and closures utilized and the drug's consistence to engender steady and acceptable outcomes.
3. Labeling Review
This review guarantees that the proposed generic pill's labeling is similar to the reference listed brand product. Few inherent disparities including description of the preparation (shape, size, color and markings), and name and address of manufacturer or distributor are permitted. Besides, the review also makes sure that the containers are well labeled, easily discernible and embrace all the information essential for the suitable supply of the generic formulation.
4. Pre-approval Inspection
During this phase, the field officers of the concerned agency inspect sites to make certain that final product fabricators, testing and packaging services are complying well with prevailing Good Manufacturing Practice (cGMP) guidelines.
After hauling a generic prescription with respect to these four reviews, the concerned agency notifies an applicant generic drugs pharmacy about any deficiency if noticed during any approval stage. If a generic product exceeds all above reviews with success, the regulatory agency will then release a final approval letter to the generic drugs pharmacy. The final approval letter permits pharmacy to fabricate and sell a generic drug in the market.
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