DRAP asks stakeholders to comment on the draft guidelines on Bio-availability & Bio-equivalence studies for generic drug products

The Drug Regulatory Authority of Pakistan (DRAP) ensures that all pharmaceutical drug products conform to acceptable standards of safety, efficacy and quality. This guidance will be applicable to orally administered generic drug products as well as to non-orally administered pharmaceutical products for which systemic exposure measures are suitable for documenting bioequivalence.

This document will provides guidance to the industry for in vivo and in vitro requirements to assure interchangeability of the generic product without compromising the safety, quality and efficacy of the pharmaceutical product.

Stakeholders can submit their comments and suggestions with 15 days of uploading of this document using prescribed format to submit comments (link to access table of comments), and forward via email to abdullah.diyo@dra.gov.pk, copying at muneeb.cheema@dra.gov.pk, or can post at mailing address Additional Director, Pharmaceutical Evaluation and Registration, 4th floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Please click to view the “Draft Guidelines on Bio-Equivalence (BE) / Bioavailability (BA) Studies for Generic Drug Products”

Stakeholders comments are invited on draft Guidelines for Labeling & Packaging of finished drug products.

This guidelines are aimed to assist industry (marketing authorization holders) in drawing up the label and package leaflet for their products in compliance with the Drugs (Labelling and Packing) Rules 1986. This documents will provide specific requirements for the labelling and packaging of pharmaceutical and biological drug products.

The purpose of the guidelines are:-

  1. To provide guidance on how to ensure that the information on the label and package leaflet is accessible to and can be understood by those who receive it, so that they can use their medicine or ensure its use safely and appropriately.
  2. To help achieve consistency, transparency, clarity, efficiency and high quality in both the content and management of reviews.
  3. This guideline is written to assist applicants and marketing authorization holders when drawing up the label and package leaflet

Stakeholders can submit their comments and suggestions with 15 days of uploading of this document using prescribed format to submit comments (link to access table of comments), and forward via email to abdullah.diyo@dra.gov.pk, copying at muneeb.cheema@dra.gov.pk, or can post at mailing address Additional Director, Pharmaceutical Evaluation and Registration, 4th floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Please click here to view draft guidance document Draft Guidelines on Labelling and Packaging of Drug Products

Import of Short Shelf Life Material(s)/Product(s).

I am directed to refer to the subject cited above and to state that the “Recommendatory Committee to Recommend Import of Short Shelf-life Drugs” in its 50th Meeting held on 18th October, 2021 decided to issue the following Advisory: –

  1. The Manufacturers/Importers be advised to apply for pre-import permission for their import consignments with Short Shelf Life. Post import cases will be considered in very exceptional circumstances of Force Majeure.
  2. The Committee further advised to charge ‘Miscellaneous Fee’ (for each Batch of Short Shelf Life Material / Product being imported) for all cases recommended after May 2021.

2. The above recommendations of the committee have been approved by the Competent Authority i.e. CEO, DRAP and the same are being communicated for compliance in true letter and spirit. please.