Medicinal Product Support in Bangladesh 
End-to-end support from experienced Regulatory experts.

Medicinal Products Regulatory Support in Bangladesh – Overview

Bangladesh has emerged as a dynamic pharmaceutical hub, known for its robust manufacturing base and expanding global exports. The Directorate General of Drug Administration (DGDA) under the Ministry of Health & Family Welfare regulates drug registration, GMP compliance, renewals, and safety surveillance.

Following CTD/eCTD-style dossier formats, the DGDA has streamlined processes for faster, more transparent approvals. Regulatory procedures covering classification, manufacturing licensing, and market authorization are guided by DGDA circulars and published timelines.

Freyr Solutions partners with pharma companies to design optimal submission strategies, prepare compliant dossiers, and liaise with DGDA for smooth and efficient market access in Bangladesh.

Medicinal Product Classification in Bangladesh & What It Means

DGDA classifies products for registration and market control; classifications determine whether a product requires full marketing authorization, simpler registration, or other controls (e.g., OTC vs prescription). Domestic law and DGDA procedures govern prescribing, dispensing, and post-market obligations. For foreign companies, local MAH/agent registration and compliance with DGDA safety and quality requirements are mandatory.

Primary categories (practical view): Allopathic Medicines, Biological Products (Biologics), Biosimilar Products, Homeopathic Medicines, Herbal Medicines, Traditional Medicines/Unani/Ayurvedic Products, Over-the-Counter (OTC) Medicines, Prescription Medicines (Rx). Classification drives dossier content, testing, and distribution controls.

Medicinal Product Drug Registration & Approval

• Pre-submission / Classification — confirm product pathway and required dossier type (CTD/eCTD guidance available).
• MAH / Local Agent & Import Licensing — foreign manufacturers must appoint a local MAH/agent and use licensed import/distribution channels.
• Dossier Submission — CTD format (Modules 1–5) is standard; DGDA provides CTD/eCTD guidance documents. Required docs: GMP certificate, CPP/Free Sale, manufacturing details, labels, stability data, etc.
• Technical Review & Committees — DGDA forms expert committees (Drug Control Committee / DCC) for technical appraisal and final decision.
• Issuance of Registration / Licensing — upon approval, DGDA issues a registration valid for a defined period; renewals are required (registrations commonly renewed every 5 years).
• Post-approval Obligations — GMP compliance, pharmacovigilance, labeling, and variation management remain ongoing responsibilities. 

Typical timelines & examples (industry-reported): retail/manufacturing licenses often take 2–4 months; marketing-authorization decisions commonly range ~4–6 months depending on dossier completeness and committee cycles. (Timelines vary by product type and DGDA workload.)