Defining roles and practices of pharmaceutical regulatory authorities

There is no doubt that regulatory authorities worldwide are facing numerous challenges in establishing efficient availability of quality pharmaceutical products, in particular tablet and capsule. It appears that a lack of clarity of objective/mandate may be the main cause of the problem, and by extension the reason there are difficulties in addressing these. The following suggestions maybe considered in addressing the current challenges.

  1. If the objective is to facilitate bringing quality products to patients, which indeed is the objective, then authorities should establish a definition of the “quality products” providing a reference quality product with associated measureable quality parameter. In the absence of a definition, it is impossible for anyone to manufacture and/or evaluate a quality product. A suggested definition in this respect is provided here.
  2. On the other hand, if the objective is monitoring the quality of the manufacturing, which appears to be the main emphasis of current regulatory practices (cGMP etc.). Then, authorities should not be in this business because this is neither their mandate nor do they possess competency/expertise in the area. They have never developed or manufactured products or run or maintain cGMP manufacturing facilities for commercial purposes. It would, therefore, be impossible to evaluate or guide the industry adequately to establish or run efficient manufacturing facilities.

Hope these suggestions would be given favorable consideration.

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