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

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.

Notification: Directions of Registration Board on the Drug Substance (DS) for Product Development, R&D, and Stability Testing

The Registration Board of Drug Regulatory Authority of Pakistan grants registration to pharmaceutical and biologicals drug products for human and veterinary use. The Drugs (Licensing, Registering and Adverting), Rules, 1976 as amended requires that applicant shall submit applications for human use on Form 5F (CTD), along with submissions of product development, and stability studies, etc under the relevant modules.

For these studies, applicants firms have to procure the Drug Substance / Active Pharmaceutical Ingredient (API) from licensed pharmaceutical manufacturers only having valid Good Manufacturing Practices (GMP) Certifications and/or Drug Manufacturing Licenses form the relevant Regulatory Authority of the Country of origin.

The DRAP Authority, upon the request of Pharmaceutical Manufacturers Association has allowed the manufacturers to acquire Drug Substance / Active Pharmaceutical Ingredient (except controlled Drugs / Substance) from another Drug Manufacturing License (DML) holders which has already imported / procured from an authorized source, only for conducting product development and stability studies to submit application for registration to DRAP on Form 5F. However, all requirements of quality and traceability would be applicable in such cases and will be the responsibility of the manufacture/applicant. Further, the products so manufactured in NO case shall be allowed for commercial sale.

The directions of DRAP Authority and Registration Board is notified accordingly.

Testing of Diethylene Glycol (DEG) & Ethylene Glycol (EG) at Central Drug Laboratory, Karachi

The Central Drug Testing Laboratory (CDL), Karachi, is providing facilities for testing of solvents (Glycerin, Propylene Glycol, and Sorbitol) used in oral preparations for the presence of any toxic impurities (e.g., Diethylene Glycol (DEG) and Ethylene Glycol (EG)) to the manufacturers and importers of pharmaceutical products. DRAP has already issued advisories and directions via letter F. No. 6-30/2022-QA dated October 21, 2022 and December 13, 2022 to the stakeholders for compliance.

Central Drug Laboratory has issued following guidance steps for manufacturers and importers for availing these facilities.

Sampling:

  1. Sampling should be made on the basis of √n + 1
  2. A composite of the quantity drawn should be made
  3. Divide this composite in three equal parts (approximately 30ml in each bottle)

Fee:

  1. Fee voucher to be generated on DRAP’s fee portal fee.dra.gov.pk by completing following steps:-
  2. a. Create Login / Enter Your Login Details
    b. Click on Generate Fee
    c. Select Division = Central Drugs Laboratory
    d. Select Payment Head = Central Drugs Testing laboratory
    e. Fee = Gas Chromatography
    f. Enter Details
  3. Fee for each batch is Rs.23000/-

Document Required:

  1. Sampling Information Sheet.
  2. Certificate of Analysis by Manufacturer.
  3. Testing Request Letter.
  4. Copy of voucher paid in any branch of Allied bank.

Testing Time:

  1. The samples will be tested on the FIFO basis.

Dispatch of Samples

  1. Three bottles as mentioned under sampling per batch shall be sent to CDL along with the
    documents mentioned above.
  2. The firm is responsible to maintain the conditions of samples during transportation.
  3. Sample should be dispatch on following Address:-
    Director, Central Drugs Laboratory
    4-B, SMCHS, Block B, Karachi

For any further assistance, Please contact to

Director, Central Drugs Laboratory, 4-B, SMCHS, Block B, Karachi or call at 021-34392159

DRAP finalized guidelines on Post Registration Variations of Pharmaceutical and Biological Drug Products

DRAP has finalized its guidelines on procedure and data requirement for post registration variation of pharmaceutical and biological drug products. This document will assist manufacturers and importers to incorporate variations in their product to account administrative changes, technical and scientific progress, or to improve or introduce additional safeguards.

These Guidelines will assist both Regulators and Industry on the regulation of variation / changes to the original registrations / Market Authorization of products in terms of procedures and criteria for the appropriate categorization, reporting of changes and subsequent approval as required. Data requirements are listed out to evaluate the impact of the proposed / intended change on the quality, safety and efficacy of the locally manufactured / imported finished pharmaceutical and biological drug products intended for human and veterinary use.

Registration holders of Pharmaceutical / Biological drug products for human and veterinary use are responsible for the safety, efficacy and quality of a finished pharmaceutical / biological drug product that is placed on the market throughout its approved life cycle. These guidelines are intended to provide supportive information for submission of post registration variation application by the registrations / marketing authorization holders of the finished drug products to implement a change. These guidelines will:-

  1. Facilitate the interpretation of the relevant regulations and decisions of Registration Board regarding post registration variations of registered drug products.
  2. Assist applicants to determine type of variation applies in each case with the classification entailing prior approval or intimation to DRAP.
  3. Provide guidance as per applicable SOPs on the conditions and other data requirements to support variance application.

The draft guidelines on data requirements for post registration variation were prepared three years ago and was available on the DRAP’ s website. Stakeholders have submitted their comments on the draft document and accordingly guidelines have been finalized after careful consideration of stakeholder’s comments.

For more information on Regulatory Guidelines published by DRAP, please navigate to Publications tabs on our website.

DRAP invited Comments from Stakeholders on the Draft Therapeutic Goods (Advertisement) Rules, 2022

Drug Regulatory Authority of Pakistan Act, 2012 under section 7 (c)(iii) and (x) mandated the DRAP for the regulation of Advertisements, enforcement and monitoring of advertisement rules and ban on false advertisement. Schedule II- B of the DRAP Act, 2012 prohibits the advertisements of any therapeutic goods except in accordance with the prescribed conditions.

The current changing trend of advertisement and promotional activities by pharmaceutical companies and the requirement of extension of scope from drugs to therapeutic goods has led to the development of these draft rules. These draft rules contain provisions almost similar to the ones given in Rule 31 of the Drugs (Licensing, Registering & Advertising) Rules 1976, included but not limited to; amended Schedule with the list of drugs permissible for advertisement as earlier consulted with stakeholders, Schedule with diseases for which advertisement is prohibited, schedule with the details on advertisement or promotional material keeping in consideration the ethical criteria; Forms for submitting applications of advertisement approval, Formats for granting approval for advertisement and schedule with details on advertisement or promotional material keeping in consideration the ethical criteria.
These draft Therapeutic Goods (Advertisement) Rules, 2022 were uploaded on the official website of DRAP dated 21st November, 2022, seeking comments and suggestions from stakeholders on the draft rules. Stakeholders can submit their comments and suggestions within 14 days of uploading this draft using prescribed format, (further information on comments submission can be accessed on this link). Comments and suggestions can be forwarded via email to aamar.latif@dra.gov.pk , copying at aqsa.hashmi@dra.gov.pk , or can be posted at mailing address, Additional Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Click here to View/Download the draft Therapeutic Goods (Advertisement) Rules, 2022

DRAP finalizes Guidelines on the Preparation of Summary of Product Characteristics (SmPC)

The Summary of Product Characteristics (SmPC) are the basic information for healthcare professionals on the use of drug products to ensure safety, efficacy and quality, and also provides a basis for preparation of the Patient Information Leaflet (PiL). SmPC describes the set of characteristics of a drug product as determined through the assessment process during registration of a drug product.

SmPC guidelines are intended to provide supportive information for preparation of Summary of Product Characteristics (SmPC) for registration / market authorization of pharmaceutical and biological products of all types including New drug products, Generic drug products and Biosimilars.

Rule 26 of the Drugs (Licensing, Registering & Advertising) Rules, 1976, as amended vide S.R.O 713(I)/2018 dated 8th June 2018, under 26(1) section 1.5.14 requires that in order to obtain registration/marketing authorization of drug product, a Summary of Product Characteristics (SmPC) is required to be included in the application dossier. The SmPC is part of drug registration / marketing authorization approval, and its contents can only be changed with the approval of Competent Authority. In this context, Registration Board has deliberated the contents of summary of Product Characteristics for pharmaceutical and biological drug products. This document transforms the decisions and advices of Registration Board into a guidance document for preparation of SmPC with application dossier submission in the CTD module.

The draft guidelines were prepared three years ago and was available on the DRAP’ s website. Stakeholders have submitted their comments on the draft document and accordingly guidelines have been finalized after careful consideration of stakeholder’s comments.

Please click to view the final document, GUIDELINES ON Preparation of Summary of Product Characteristics

For more information on Regulatory Guidelines published by DRAP, please navigate to Publications tabs on our website.

Notification: Applications for Registrations of Pharmaceutical drugs submitted on Form 5/5D requiring submission of Product Stability Data

Registration Board in 320th meeting held on 29th – 31st August 2022 has issued a direction with regards to the applications received on Form 5 / 5-D for registration of pharmaceutical drugs, which requires submission of stability study data for further processing. The list of such applications is available on official website of DRAP (link).

The decision of Registration Board is notified and attached hereunder for information and compliance by all relevant stakeholders.

Policy for Inspection of Manufacturing Site Abroad

Policy Board of the Drug Regulatory Authority of Pakistan (DRAP) has given policy guidelines for inspections of manufacturers keeping in view the suggestions/guidelines of WHO for reliance on other regulatory authorities. Accordingly, the revised “Policy for inspections of manufacturers abroad” as approved by the Policy Board under Section 11 (I) (a) of the DRAP Act, 2012, as under:-

Proposed amendments in the Rules : DRAP invites comments from stakeholders and public on the draft amendments in the Drugs (Licensing, Registering and Advertising) Rules, 1976;

The Drug Regulatory Authority of Pakistan (DRAP) has issued a proposal to amend the current version of the Drugs (Licensing, Registering and Advertising) Rules, 1976. The proposed amendments relates to the minimum area requirement for establishment of a pharmaceutical manufacturing units and adoption of Pharmaceutical Inspection Cooperation / Scheme (PIC/S) Guidelines for Good Manufacturing Practices (GMP), in order to further align more closely with the international standards and best practices, as practiced by many other regulatory authorities around the world.

The DRAP proposes to do so primarily by incorporating the provisos to enable manufactures and regulators to follow principles set by the Pharmaceutical Inspection Cooperation / Scheme (PIC/S) to maintain the quality standards at an acceptable level. PIC/s guidelines provide comprehensive guidance for both industry and regulators on various aspects of Good Manufacturing Practices.

DRAP has the mandate to issue guidelines and to monitor enforcement of licensing of manufacture of therapeutic goods and to implement internationally recognized standards under Section 7(c)(i) & (ix) of the DRAP Act, 2012. Control of environmental conditions for pharmaceutical industry is essential to manufacture quality products. and implementation of Good Manufacturing Practices (GMP) guidelines is critical to ensure the proper design, monitoring, and control of the manufacturing processes and facilities.

Stakeholders can submit their comments within 14 (fourteen) days of the publication of this Notification in the official Gazette of Pakistan using prescribed format, via email to aamar.latif@dra.gov.pk, or can be posted at mailing address, Deputy Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad. Further information on comments submission can be accessed on this link.

SRO 778 (I)/2022 dated 10th June, 2022