DRAP services

05/08/2025

🚨 DRAP Introduces Priority Review for Quality Dossiers!
🚨 ڈریپ نے معیاری درخواستوں کے لیے ترجیحی جانچ کا آغاز کر دیا!

To encourage local manufacturers, DRAP will now prioritize drug registration applications that meet the following quality standards:

✅ Full CTD (Form 5F) submission without exemptions
✅ Robust drug stability and impurity data
✅ Acceptable bioequivalence studies

یہ سہولت ان مینوفیکچررز کے لیے ہے جو:
✅ مکمل فارم 5F (CTD) ڈوزیئر بغیر کسی چھوٹ کے جمع کروائیں
✅ مکمل اسٹبیلٹی اور امپیورٹی ڈیٹا شامل کریں
✅ منظور شدہ بایو ایکویولینس اسٹڈیز پیش کریں

This is a positive step toward strengthening scientific excellence and faster approvals in Pakistan's pharma sector.
یہ اقدام پاکستان کی فارما انڈسٹری میں معیار اور رفتار کو بہتر بنانے کے لیے خوش آئند ہے۔ 💊🇵🇰

04/08/2025

🚨 Important Regulatory Update for the Pharma & Medical Device Industry in Pakistan 🚨

DRAP (Drug Regulatory Authority of Pakistan) has officially revised the regulatory fee structure for therapeutic goods, including pharmaceuticals, medical devices, and nutraceuticals.

04/08/2025

Revised DRAP regulatory FEE.

04/08/2025

31/07/2025

Malaysia Takes Global Lead in Medical Device Regulatory Reliance 🌍🔬

Exciting news from Malaysia! 🇲🇾
The Ministry of Health Malaysia and the Medical Device Authority (MDA) have launched a first-of-its-kind international Medical Device Regulatory Reliance Programme with China.

This initiative, announced during HIMSS APAC 2025, allows both countries to mutually recognize regulatory decisions for faster medical device approvals. 🇲🇾🤝🇨🇳

✅ Malaysian IVDs may access China’s Green Channel
✅ Chinese IVDs can use Malaysia’s Verification Pathway
⏱ Approval timelines reduced to 60 and 30 days!

This move reduces duplication, boosts market access, and positions Malaysia as a regional regulatory hub — attracting global healthcare innovation and investment.

📅 Official rollout: 30 July 2025
🗣 Industry stakeholders are invited to engage with MDA for collaboration.

31/07/2025

📢 Regulatory Update for Distributors & Importers in Lahore

The District Health Authority, Lahore has officially directed all licensed distributors and authorized agents in Gulberg Town to seek DRAP approval before increasing the MRP of Essential Drugs/Biologicals.

As per DRAP’s Drug Pricing Policy and Section 12 of the Drug Act 1976, no manufacturer or importer is allowed to change prices without prior written approval.

🚨 Overpricing will be treated as a punishable offense under the Drug Act 1976 and DRAP Act 2012.

A model list of essential medicines has been enclosed for reference.

📄 Issued by: Waleed Javaid, Drugs Inspector – Gulberg Town, Lahore
📆 Dated: 30-07-2025

29/07/2025

94th Meeting of Medical Device on 31ST Jully