Medicinal Product 
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Medicinal Products Regulatory Support in Pakistan – Overview

Pakistan’s pharmaceutical market is expanding rapidly, driven by healthcare reforms and Regulatory modernization under DRAP. All medicinal products must be registered before marketing, import, or distribution. DRAP, through its divisions — Pharmaceutical Evaluation & Registration (PE&R) and Drug Licensing (DL) — ensures compliance with quality, safety, and efficacy standards.

To obtain registration, companies must submit a CTD-format dossier, provide GMP certification, and meet local labeling and pricing norms.
Freyr supports pharmaceutical manufacturers and importers through every step, ensuring Regulatory accuracy, compliance, and timely approvals.

Medicinal Product Classification in Pakistan

Medicinal products are governed under the Drug Act, 1976 and categorized as follows:

• Prescription Drugs (Rx): Require medical supervision and are dispensed only with a valid prescription.
• Over the Counter (OTC) Drugs: Approved for self-medication with proven safety and efficacy.
• Biological and Biotechnological Products: Require additional data on biosimilarity and comparability.
• Controlled Substances: Subject to strict licensing and reporting under the Control of Narcotic Substances Act.

All products must be registered with DRAP, and sale or distribution of unregistered drugs is prohibited.

Medicinal Product Registration & Approval Process in Pakistan

Regulatory Authority: Drug Regulatory Authority of Pakistan (DRAP)
 Legislation: Drug Act, 1976; DRAP Act, 2012

Key Steps:

1. Licensing

• Company must hold valid Drug Manufacturing License (DML) or Drug Import License (DIL).
• Site must comply with GMP standards approved by DRAP.

2. Dossier Submission

• CTD format (Modules 1–5).
• Includes product details, GMP certificates, CPP, stability data, and labeling.

3. Screening & Evaluation

• DRAP reviews completeness and technical adequacy.
• Evaluation includes safety, efficacy, quality, and reference country approvals (where applicable).

4. Pricing Approval

• Prices must be approved by DRAP’s Costing & Pricing Division before marketing.

5. Registration Grant

• Issuance of Registration Certificate (Form 6) with a validity of 5 years.

6. Post-Registration Requirements

• Import permissions for each consignment.
• Local labeling compliance (English/Urdu).
• Post-marketing surveillance and pharmacovigilance reporting.

Specific Requirements by Product Type 

• Generics: Require bioequivalence data or justification.
• Biologics/Biosimilars: Must meet WHO and DRAP biosimilarity standards.
• Vaccines: Require lot release certification from the National Control Laboratory for Biologicals (NCLB).
• OTC Products: Simplified submission but strict labeling and safety evaluation apply.

Post-Approval & Pharmacovigilance 

Registered products are subject to continuous oversight by DRAP:

• Renewal: Every 5 years, with updated stability, GMP, and safety data.
• Variations: Any changes in formulation, labeling, or manufacturing must be approved before implementation.
• Pharmacovigilance: MAH must establish a local safety officer and ADR reporting system as per Pharmacovigilance Rules, 2022.
• Market Surveillance: Regular sampling, inspections, and product quality reviews by DRAP.

Freyr ensures end-to-end lifecycle management for continued compliance in Pakistan.