Regulatory Approval: General view

Before a pharmaceutical product can go to a new market or developing market, filling must be composed and filed with all relevant regulatory agencies to seek a review and finally regulatory approval. Each jurisdiction has its own procedures or procedures to review drug submissions filed to their regulatory authority. These procedures can change considerably with respect to

  • How the drug submission will be managed,
  • The constitution of the review team,
  • Review timelines etc; In spite of the divergences, the procedures to turn over regulatory approval generally follow these stages:

Pre filling or Pre-Submission meeting:

Even though left to personal choice, a pre filling meeting is often helpful so that any regulatory submission issues can be discussed and settled well in advance to the actual filling. This meeting allows the regulatory authority insight in to the proposed submission and permits them to bring their internal resources in accordance with. Ensure the challenges are talked over are addressed in the submission dossier, with further more details or a strong scientific explanation furnished.

Pre submission Activities:

Appraise critically what communication is necessitated before submitting marketing application.

Administrative Review:

As soon as a drug submission is registered or filed, it goes through administrative review to ascertain its acceptability. A submission number is allotted and this number must be used in all later communication with the regulatory authority.

If the drug submission is observed to be acceptable at this point, it will be accepted for review. If minor deficiencies are observed, the authority will generally permit the time to respond applicant. If the response is meeting requirements, then the application will go forward for review. If the applicant fails to provide the required information within the given timeline or if that the reply is inadequate, the regulatory authority can refuse the application.

Regulatory review and Applicant Response:

Once a filling is accepted by regulatory authority, it is assessed by scientific committee of that regulatory agency. The objective of the review is to support and prove valid the applicants conclusion that the product is safe and effective for its proposed therapeutic indication.

After the scientific review is finishes, an assessment report will be generated. If the filling took for acceptable, then the review of the submission is complete. If deficiencies are observed, then authority will send list of questions for the applicant to address within a set of timeline.

These inspections also assess the text in the proposed labeling that needs to be freed by the data submitted in the filling. If the reviewers question the proposed labeling, they will talk over revised label contents with the applicant.

Activities prior to the Agency’s Decision:

These may include any essential pre approval inspections for instance: inspection at plant or inspection at clinical trial sites:

Regulatory Decision:

The decision made at the end of the review generally leads in drug agency approval, it mean product approval with condition or a rejection.

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