Drug Regulatory Authority of Pakistan, on the recommendations of the Registration Board has issued guidance for submitting applications for registration of pharmaceutical product with multiple strengths and different fill volumes. The Notification issued in this regard is as under:-
Regulatory Updates
Notification: Application on Form-5F (CTD) for Extension in the Contract Manufacturing Permission of Drugs.
Drug Regulatory Authority of Pakistan on the recommendation of the Registration Board has revised the data requirement for submitting applications for extension in the contract manufacturing permission of the drugs for those product where CTD dossiers has already been submitted and approved by the Registration Board. The Notification issued in this regard is as under:-
SRO 685(I)/2023 dated 09-06-2023: Amendments in the Bio Study Rules, 2017
The Drug Regulatory Authority of Pakistan, with the Federal Government’s approval, has made amendments to the Bio-Study Rule 2017. Through this amendments, the Application Form (Form-IIA) for BA/BE Studies has been revised to rationalize the requirement for submission of the reference product’s Certificate of Pharmaceutical Products (CoPP). The Notification issued in this regard is as under:-
SRO.649(I)/2023: MRP fixation of Cardiac Stents
Drug Regulatory Authority of Pakistan with approval of the Federal Government, in exercising its powers conferred by subclause (vii) of clause (c) of section 7 of the Drug Regulatory Authority of Pakistan Act2012 (XXI of 2012) readwith section 1 2 of the Drugs Act, 197 6 (XXXI of 197 6) has notified the maximum retail prices of cardiac stents as specified hereunder:-
Updated Database of Pharmaceutical and Biological Drug Product
The Drug Regulatory Authority of Pakistan (DRAP) has updated the database of pharmaceutical and biological drug products. This database is available for public access through DRAP Website and contain information on the drugs registered by the DRAP including the Name of Product (brand/proprietary name), Dosage Form, Composition / Active ingredients, Registration Number, Registration Date, Market Authorization holder and Manufacturing company.
The publicly accessible version of this database is for reference purposes only and is subject to a disclaimer. It provides information on the registered pharmaceutical and biological drug products that can be supplied through authorized establishments (pharmacies/retail outlets or healthcare institutions) in Pakistan.
Related News
- Implementation of Post Registration Variation Guidelines for Pharmaceutical and Biological Products (2nd Edition)
- Switching Over to Pakistan Single Window (PSW) for Drug Import License and Import Release of Donations Medicines
- Guidelines on Risk Based Sampling and Testing of Drugs; Comments invited on draft Document
- Important Notice to INGOs, NGOs, Hospitals and Government Programs/Departments Importers of Donated Drugs in Pakistan
Note: This database reflects the record of the contents available with the respective Divisions of DRAP. It is not intended to provide any guidance, advice or recommendations on these products.
Unless exempted through special permissions, any pharmaceutical or biological products that is not registered with DRAP cannot be imported or supplied in Pakistan.
For Market Authorization Holders:-
DRAP has transformed manual operation to PIRIMs, marketing authorization holders of pharmaceutical and biological drug products are requested to review and update their finished products Specifications. In this context, a notice was issued and uploaded on the website of DRAP on 13th March, 2023 and 20th April, 2023 (link), with the direction to all Registration Holders of pharmaceutical and Biological drug products to update finished products Specifications. The requisite information must be provided before 09th June, 2023.
Recall Alert: Medical Devices; Aquavent Neonatal Breathing Circuits by M/s. Armstrong Medical Limited, Ireland
Recall Alert
| DRAP Alert No | No I/V/05-23-23 |
| Action Date | 17th May 2023 |
| Target Audience | -Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Pharmacists, and Nurses. -Procurement Officers at Hospitals and Healthcare Institutions, -Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores |
| Product(s) Affected | AQUAVENT NEO Neonatal CPAP limb (Ventilator breathing circuit) Manufactured by: Armstrong Medical Limited, Northern Ireland, Distributed by M/s. Elate C.C (Pvt) Ltd. Karachi, Pakistan Batch No. 230123 (230123 as per the list in the Field Safety Notice) |
| Problem / Issue | Armstrong Medical Limited, Ireland received reports for their Neonatal Breathing Circuits for risk of patient harm as a result of tubing (and a connector attached to the tubing) disconnecting from the elbow within Neonatal Breathing Circuits. Accordingly, the manufacturing company has issued a field safety notice and initiated recall of the defective product from the international market including Pakistan. |
| Action Initiated | -The manufacturing company has initiated a recall of the affected lots of defective products from the market where it was distributed. -All healthcare professionals working in critical care units of hospitals as well as pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these lots of the product. The remaining stock should be quarantined and returned to the supplier/company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk. -Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | -DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return this product’s defective batch(es) to the importer/company. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP. |
| Advice for Consumers | -Consumers should stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this Medical Device. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist. |
DRAP invites Comments on Draft Guidance Document for Submission of Application on Form 5F (CTD) for Registration of Biological Drug Products for Human Use
This guidance is developed to assist manufacturers and importers in developing their applications for registration of human biological drug products. Drug Regulatory Authority of Pakistan (DRAP) has adapted CTD format for registration of all such drugs vide SRO-713(l)/2018 dated 8th June 2018. Detailed guidance regarding the data requirement for CTD format has been provided in ICH M-4 guidelines. Since the DRAP is introducing the CTD in a progressive manner, therefore, initial guidance to applicants would be helpful for harmonization and appropriate data submission to achieve consistency and uniformity of application.
The guideline is intended to provide data requirements of Form-5F (CTD) for registration / market authorization of biological products of all types including New drug products, and Biosimilars. This document provides guidance for importers and local manufacturers of human biological products on how to obtain market authorization / registration in the territory of Pakistan.
This draft guideline is uploaded on the official website of DRAP dated on 9th 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 prescribed format, (further information on comments submission can access on this link. Comments and suggestions can be forwarded via email to a ahmad.ansari∂dra.gov.pk copying at ahsan.hafiz∂dra.gov.pk , or can be posted at mailing address, Director, Biological Drugs, Drug Regulatory Authority of Pakistan, 4th floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.
Stakeholders’ Comments are invited on the Draft Guidelines on Patient Information Leaflet
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.
DRAP issued a Draft of Guidelines on the Lot Release of Biological Drugs
The lot release of biological products is a part of the regulation of biological products. It involves the independent assessment of each lot of a licensed biological product before it is released in the market. In addition to manufacturing, the complexity inherent to biological products, proper storage conditions and efficient supply chain management must be ensured to preserve these products’ sensitivity and limited shelf life properties. For the reasons stipulated above, a careful independent review of manufacturing and quality control data on every lot of product as stated is, therefore, necessary before use. Lot release program enables National Regulatory Authority (NRA) to ascertain the safety, quality, and effectiveness of every lot of these products.
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, (further information on comments submission can access at this link. Comments and suggestions can be forwarded via email to ayub.naveed∂dra.gov.pk, copied at director∂nclb.dra.gov.pk, or can be posted at the mailing address, The Director, National Control Laboratory for Biologicals, Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Chak Shehzad, Islamabad.