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Regulatory Approval: General view

posted by Harneedi on May 10, 2017
tags: Regulatory approval Pharmaceutical Market

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.

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