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

PAKISTAN (DRAP)

DRAP Encourages Users to Update the Med Safety App

DRAP has advised users of its Med Safety App to install the latest update, which introduces enhanced features and bug fixes. The update—developed by the UK MHRA—allows Pakistan’s National Pharmacovigilance Centre to request more targeted information based on patient-submitted reports.

Notice to Pharmaceutical and Biological Importers and Manufacturers

DRAP has deployed the Pakistan Integrated Regulatory Information Management System (PIRIMS) for all activities related to licensing, inspections, and registration. All registration holders must update finished product specifications and validated test procedures in PIRIMS within the 30-day window provided in the official notice.

DRAP Initiates Recall of Ethylene Glycol–Contaminated Products

DRAP is urgently recalling seven products manufactured by Davis Pharmaceutical Laboratories after ethylene glycol contamination was detected, including a batch previously flagged by Gambia’s Medical Control Agency. Four of the affected products were intended for export. Contaminated glycerin and propylene glycol sources are suspected to be the cause.

Consultation on Amendments to the Drugs (Research) Rules, 1978

DRAP has issued draft amendments to the Drugs (Research) Rules, 1978, and invited stakeholders to submit feedback within 14 days of the publication date. Comments may be sent by email or submitted in hard copy to the DRAP Legal Affairs Division.

MALAYSIA (NPRA)

Declaration Template for Worldwide Registration Status of Generic Medicines

NPRA has released a standard template to capture worldwide registration status (WWRS) of prescription generic medicines. Applicants must use the updated form for all new submissions made through the Quest online system.

EGYPT (EDA)

Updated Biosimilar Registration Guideline

EDA has published an updated biosimilar registration guideline aligned with current international evaluation principles. It should be read in conjunction with the regulatory framework established under EDA Presidential Decree No. 343/2021 and reliance pathways for biological product registration.

CTD Quality Module Guidance

EDA has also released guidance detailing the required documentation for preparing the CTD Quality Module for human pharmaceuticals. The guidance aligns with applicable ministerial decrees and technical committee decisions.

PHILIPPINES (FDA)

Regulatory Reliance Guidelines for Clinical Trials

The Philippine FDA has issued guidance on applying regulatory reliance to streamline the evaluation of clinical trial applications. Under the abridged pathway, decisions from recognized regulatory authorities—such as EMA and FDA—may be used to expedite approvals. Fourteen authorities have been designated as reference agencies.

URUGUAY

Launch of the Regional “Health Intelligence Node”

Uruguay has created a Health Intelligence Node to strengthen regional cooperation, improve information sharing, and support decision‑making among health authorities within Latin America.

INDONESIA (BPOM)

Fourth Amendment to Drug Registration Regulation

Indonesia’s BPOM has amended portions of Regulation No. 24/2017 concerning drug registration. Updates include changes to the variation categories, requirements, and documentation needed for registration applications.

AUSTRALIA (TGA)

Consultation on Significant Fee Increases

TGA has proposed notable increases to annual fees and charges driven by inflationary pressures and efforts to recover investments in digital transformation and new laboratory facilities. A 5.2% indexation factor is planned, with additional increases to recover government-funded upgrades.

SOUTH KOREA (MFDS)

Analytical Methods for Mutagenic Impurities

MFDS has published validated analytical methods for detecting mutagenic impurities in drug substances and drug products. The methods may require verification or adaptation depending on the testing environment and may evolve with future research.

UGANDA (NDA)

Updated Guidelines for CTD Dossier Submission

Uganda’s NDA has issued CTD-format dossier preparation guidelines for human pharmaceutical products containing existing or newly developed synthetic APIs. The guidelines exclude vaccines, biotherapeutics, biosimilars, and herbal formulations.

SOUTH AFRICA (SAHPRA)

Updated Form for Adverse Drug Reaction and Quality Issue Reporting

SAHPRA has released an updated reporting form applicable to both public and private sectors. The form covers adverse drug reactions and quality complaints, including reports related to herbal products.

TANZANIA (TMDA)

Reminder to Register and Update Clinical Trial Information

TMDA reminds sponsors and principal investigators that all approved clinical trials must be registered in the National Clinical Trial Registry within 21 days of enrolling the first participant. Registrations must be kept current through trial completion as required by national regulations.