Pharma DRA

Pharma DRA Pharma & Medical device registration related knowledge sharing in Bangladesh.

Medical device & Diagnostic reagents registration
Project plan submission of new pharma plant
Import registration of finished medicines
Validity extension of existing products
Retail & wholesale pharmacy license
Manufacturing license renewal
Block list & indent submission
New product registration

Our Apostille Services Include:-Fast & authenticated document processing-Legalization for international use-Birth certif...
23/01/2026

Our Apostille Services Include:
-Fast & authenticated document processing
-Legalization for international use
-Birth certificates, degrees, commercial papers & more
-Compliance with Hague Convention standards
Why deal with embassy queues and confusing rules? Let our experts handle it for you—quickly, legally, and hassle-free!

DGDA issued a Public Notice to control and regulate the food supplement, Dietary supplement, Herbal supplement and medic...
30/12/2025

DGDA issued a Public Notice to control and regulate the food supplement, Dietary supplement, Herbal supplement and medical nutritions. Food supplement, Dietary supplement, Herbal supplement, nutritional supplement, medical nutrition and therapeutic nutrition have been defined by the Drug and cosmetics act, 2023. So, food supplement products are under the jurisdiction of Directorate General of Drug Administration (DGDA). Registration application will be placed in DCC for evaluation.

As per the DGDA circular no.: DGDA/bibidh-07/1098; date: 24-Dec-2025

Required documents for import registration of Food supplement under the jurisdiction of DGDA:

1. Application to DGDA with the Letter of Authorization issued by the manufacturer.
2. Declaration letter issued by the Chamber of commerce of the country of origin.
3. FSC/CPP issued by the Regulatory Authority of the Country of Origin – Attested by the Bangladesh embassy in the Country of Origin
4. FSC/CPP issued by the Regulatory Authority of any of the reference country, EU, USA, UK, Switzerland, Canada, Australia, Japan, South Korea, Singapore, Russia – Attested by the Bangladesh embassy (Reference country’s FSC/CPP is required if the Country of Origin is outside these countries)
5. Material safety data sheet (MSDS)
6. Certificate of Analysis (COA)
7. Product test method and composition detail
8. Manufacturing process
9. Stability Data (6 months accelerated and the real time stability data of the shelf life)
10. Product packaging, box, label – Draft
11. Wholesale license
12. Government registration fees BDT 5750 (as primary application fees) + BDT 57,500 (as final registration fees)

Product’s brand name or, trade name must be reflected in the FSC or, CPP issued by the reference country. That means only the same brand products which are exported or, freely sold in any one of the reference countries (Serial no. 4) can be registered in DGDA, Bangladesh.

11/12/2025

Beacon Pharmaceuticals PLC এর Managing Director, মোঃ এবাদুল করিম বুলবুল স্যারের মৃত্যুতে আমরা গভীরভাবে শোকাহত। মহান আল্লাহ তায়ালার কাছে উনি ভালো থাকুন, আমরা এই দোয়া করি।

pharmadra.com
22/10/2025

pharmadra.com

Visit our website for more details.
14/10/2025

Visit our website for more details.

CTD format as per ICH:Module 1: Regional administrative & prescribing informationModule 2: Quality overall summary (QOS)...
02/10/2025

CTD format as per ICH:
Module 1: Regional administrative & prescribing information
Module 2: Quality overall summary (QOS) & Table of content (TOC)
Module 3: Quality Data
Module 4: Safety Data (Non-Clinical study reports)
Module 5: Efficacy Data (Clinical study reports)

25/09/2025
Required Documents for the renewal of retail drug License.
22/06/2025

Required Documents for the renewal of retail drug License.

06/06/2025

জনবহুল এলাকায় ও জনসমাগমস্থলে Facemask ব্যবহারের জন্য পরামর্শ দিয়েছে, স্বাস্থ্য ও পরিবারকল্যাণ মন্ত্রণালয়, বাংলাদেশ I

Address

East Maniknagar
Dhaka
1203

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