Pharma/Biotech – Asia, ROW Regulatory News, Jan 2023 Vol. 2

ASIA

MALAYSIA (NPRA)

Guide for Adverse Drug Reaction (ADR) Reporters

NPRA has released updated guidance aimed at improving the quality of ADR submissions. The document includes checklists for reporters, instructions for laboratory testing in suspected adulteration cases, and steps for accessing global ADR information sources.

CHINA (CDE – NMPA)

Implementation of E2B (R3) for Clinical Trial Safety Reporting

To support adoption of the E2B (R3) Regional Implementation Guide for Individual Case Safety Reports, the Centre for Drug Evaluation has completed upgrades to its pharmacovigilance system used during clinical trials. The updated system has been in trial operation since 1 January 2022. All applicants must configure the system and fully implement E2B (R3) reporting no later than 1 July 2022.

ARMENIA

Revised Variation Guideline

Armenia has issued a detailed variation classification guideline for medicinal products. If an applicant intends to submit a variation not covered by the guideline, they may request classification advice from the Scientific Centre. Recommendations are provided within 45 days of request receipt.

INDIA (MOHFW)

Draft Amendment – New Drugs and Clinical Trials Rules, 2019

The Ministry of Health and Family Welfare has published draft amendments to the New Drugs and Clinical Trials Rules, 2019 (Third Amendment). The update introduces several new forms, including CT-02A, CT-06A, CT-07A, CT-11A, CT-14A, and CT-15A.

PAKISTAN (DRAP)

Guidance on Reference Product Data for Pharmaceutical Equivalence and CDP Studies

DRAP’s Registration Board has released guidance on preparing applications under Form 5-F (CTD) for human drug product registration. Applicants must submit pharmaceutical equivalence and comparative dissolution profile (CDP) data as part of the formulation development section (3.2.P.2.2.1).

Guidance on Drug Substance Requirements for Product Development and Stability Studies

DRAP has clarified requirements for sourcing drug substances used in product development and stability studies. Applicants must procure APIs from licensed pharmaceutical manufacturers that hold valid GMP certification or a manufacturing license from the regulatory authority of the country of origin.

Stakeholder Consultation on Draft Good Manufacturing Practice (GMP) Guideline

DRAP has issued a draft GMP guideline consolidating expectations for pharmaceutical and biological manufacturers. Stakeholders may submit comments within 15 days of publication using the prescribed format. Submissions may be emailed to the listed DRAP contacts or mailed to the Quality Assurance & Lab Testing Directorate.

REST OF WORLD (ROW)

TANZANIA (TMDA)

Annual Retention Fee Requirement for 2023

TMDA reminds marketing authorization holders that annual product retention fees must be paid by 31 January 2023 to maintain registration status. Import permits will not be issued for any product whose fee remains unpaid after the deadline. Invoices may be collected from TMDA’s Eastern Zone Offices or Headquarters.

Checklist for Screening Registration Applications

To help ensure complete submissions, TMDA has published a screening checklist for human medicinal product registration applications. The checklist is intended as a supplementary tool and should be used alongside all applicable regulatory guidelines.

BAHRAIN (NHRA)

Compliance with NHRA-MVC Traceability Hub

In line with Resolution No. 41 (2017) and Circular No. 17 (2022), Bahrain requires all imported pharmaceutical products to comply with national serialization and traceability requirements. Products must be entered into the NHRA-MVC Traceability Hub following the Medicines Barcoding and Serialization Guideline (Version 1.2, 2019).

SAUDI ARABIA (SFDA)

SFDA Achieves Accreditation for Facility Inspections

The Saudi Food and Drug Authority has received an accreditation certificate recognizing its inspection capabilities for food, drug, and medical device facilities. This marks the fifth consecutive renewal of accreditation under the ISO/IEC 17020:2012 standard.

Updated GMP Guide for Medicinal Products – Version 4.2

SFDA has released Version 4.2 of its GMP guidance for medicinal products. The revised guideline includes updated requirements for the manufacture of sterile medicinal products, which will come into effect on 25 August 2023.