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Stakeholders’ Comments are invited on the Draft Guidelines on Patient Information Leaflet

Asad Ullah General, News & Updates, Notifications, Regulatory Updates ,

The Patient Information Leaflet (PIL) provides essential information to patients and caregivers on the use of drug products ensuring their safety, efficacy, and quality. It describes the information for patients that ensures the safe and effective use of medicine under most circumstances. The PIL is a document that is updated as new data emerges related to drug product safety, efficacy, and quality or use. The registration/market authorization holder is responsible shall supply any new information without delay which may require the variation of the marketing authorization/registration including the revision of PIL.

The guideline is intended to provide supportive information for preparing a Patient Information Leaflet (PIL) for registration/market authorization of pharmaceutical and biological products of all types including New drug products, Generic drug products, and Biosimilars. This guideline provides advice on the principles of presenting information in the PIL.

This draft guideline is uploaded on the official website of DRAP dated 5th May 2023, for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using the prescribed format. For further guidelines on submitting comments, visit DRAP website or click here. Comments and suggestions can be emailed to haseeb,tariq∂dra.gov.pk, copied at addl-dir.pe.reg∂dra.gov.pk, or posted at the mailing address, Director, Pharmaceutical Evaluation & Registration, Drug Regulatory Authority of Pakistan, 4th-floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

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Notification: Directions of Registration Board on Labeling Requirements of Drug Products to Comply Pharmacopeial Specifications for Dissolution Testing

Asad Ullah Drugs, Notifications, Regulatory Updates , , ,

Registration Board in its 323rd meeting observed that various USP monographs for drug products prescribe more than one dissolution tests and that the pharmacopoeia in such cases recommends that “When more than one Dissolution Test is given, the labeling states the Dissolution Test used only if Test 1 is not used.”

Keeping in the USP labeling requirements narrated above and to comply to the Pharmacopeial specifications, the Board decided as under:

“The manufacturer shall mention the dissolution test Number on the secondary packing / unit carton of product for dissolution tests No 2,3 or 4 as per requirement of USP otherwise it would be presumed that dissolution test No.1 shall be performed on the finished product.”

Accordingly, the decision of Registration Board is circulated for information and compliance by relevant stakeholders / manufacturers.

Notification: Directions of Registration Board on Reference Product data submissions for conducting Pharmaceutical Equivalence and Comparative Dissolution Profile Studies

Asad Ullah Drugs, Notifications , , ,

Registration Board of DRAP has issued a Guidance document for applicants on submission of application on form 5-F (CTD) for registration of pharmaceutical drug products for human use. Submission of data of pharmaceutical equivalence and Comparative Dissolution Profile (CDP) is required under section 3.2.P.2.2.1 (Formulation Development) of Form 5F (CTD).

In order to further harmonize the submission of such data and ensure data integrity, Registration Board in its 322nd meeting held on 8th & 10th November, 2022 decided as under:

“Firm shall submit the image/picture/snapshot of the innovator/reference/comparator pack against which Pharmaceutical equivalence / Comparative Dissolution Profile studies have been performed and shall reveal the details of brand name, manufacturer, batch# and expiry date of the innovator/reference/comparator product in the section 3.2.P.2.2.1 (Formulation development) of Form 5F.“

Accordingly, above decision of Registration Board is hereby notified and circulated for information and compliance by relevant stakeholders / applicants.

Stakeholders Comments are invited on the Draft Guidelines on Good Manufacturing Practices (GMP)

Asad Ullah Publications, Regulatory Updates , ,

Although the Drugs (Licensing, Registering & Advertising) Rules, 1976 under the Drugs Act, 1976 provides detail requirements on Good Manufacturing Practices (GMP), however, DRAP intends to provide a compiled GMP guidance document stipulating Drug Regulatory Authority of Pakistan’s (DRAP) expectations on GMP from pharmaceutical & biological drugs manufacturers.

This document is intended to provide guidance regarding Good Manufacturing Practices (GMP) for the manufacturing of pharmaceutical & biological drug in accordance with the Drugs (Licensing, Registering & Advertising) Rules, 1976, under the Drugs Act, 1976, the good manufacturing practices aim at ensuring that:

  1. Products are consistently produced and controlled to the quality standards appropriate to their intended use
  2. Products are manufactured as required by the marketing authorization or product specification; and
  3. All those risks have been diminished that are inherent in any pharmaceutical / biological production operation, including contamination, cross contamination and mix ups (confusion) that cannot be detected completely through the testing of final products.

This draft guideline is uploaded on the official website of DRAP dated 5th January, 2023 seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format, (further information on comments submission can be accessed on this link). Comments and suggestions can be forwarded via email to ajmal.sohail∂dra.gov.pk, copying at hasan.afzaal∂dra.gov.pk , or can be posted at mailing address, Additional Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

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