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

ASIA

MALAYSIA

Revised Guideline for Facilitated Registration Pathway (FRP) 

Malaysia’s NPRA has updated its Facilitated Registration Pathway (FRP) guideline. The revised framework now includes registration schemes eligible for abbreviated and verification review and expands the list of recognized Drug Control Authority (DCA) reference agencies. The updated scope covers not only new drug products and biologics (including CGTPs) but also generic medicines. Revisions include updated eligibility criteria, documentation requirements, timelines, dossier checklists, and detailed process flowcharts.

PAKISTAN

Draft Guideline on Storage and Destruction of Substandard/Falsified (SF) and Recalled Therapeutic Goods 

DRAP has issued a draft guideline outlining procedures for storing and destroying recalled therapeutic goods, including medicines, medical devices, and health products that are substandard or falsified. The document covers identification, reporting, safe handling, disposal, and recordkeeping to ensure effective management of recalled products.

New eService for Online Submission of Pharmaceutical and Biological Product Registration 

DRAP has launched a new eService enabling online submission of regulatory data for registration and marketing authorization of human medicinal products for manufacturing, import, and export. This digital platform—already used for licensing operations—supports Pakistan’s transformation strategy aimed at ensuring the quality, safety, and efficacy of therapeutic goods. Applicants must upload registration data in a standardized format.

SINGAPORE

HSA Designated as WHO-Listed Authority (WLA) 

Singapore’s Health Sciences Authority (HSA) has been designated as a WHO-Listed Authority for its medicines regulatory system as of 26 October 2023. This global recognition reflects HSA’s advanced regulatory performance, high standards of safety, efficacy, and quality assessments. HSA previously achieved WHO Maturity Level 4 in 2022. A comprehensive review by international assessors between October 2022 and March 2023 evaluated assessment quality, scientific robustness, decision consistency, and operational implementation.

CHINA

NMPA Becomes Official PIC/S Applicant 

China’s NMPA submitted its formal application to join the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in September 2023. PIC/S confirmed NMPA’s applicant status on 8 November 2023. As an applicant, NMPA aims to enhance cooperation with PIC/S, strengthen its drug inspection system, elevate quality management, and support modernization of national drug regulation.

REST OF WORLD (ROW)

SOUTH AFRICA

2024 Clinical Trials Committee Schedule 

SAHPRA has published Clinical Trials Committee meeting and submission deadlines for 2024. Applicants are advised to submit clinical trial applications before the specified due dates, as late submissions will not be accepted.

AUSTRALIA

Global Medicines Safety Awareness Campaign 

The TGA is once again partnering with global regulators to support #MedSafetyWeek, held from 6–12 November. The campaign encourages consumers and healthcare professionals to report suspected adverse events, an essential part of pharmacovigilance and early safety signal detection.

Updated List of Medicine Ingredients (October 2023) 

The TGA has updated permissible ingredients under the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2023, effective 25 October 2023. This replaces Determination (No. 3) 2023 and includes revised ingredient conditions for listed medicines.

New Adverse Event Search Function for Sponsors 

The TGA has introduced enhanced search capabilities through the Adverse Event Management System (AEMS). Sponsors can now self-access TGA-held adverse event reports, apply filters, and download de-identified Public Case Detail (PCD) and Case Line Listing (CLL) reports for integration into their pharmacovigilance systems.

MEXICO

Cofepris Enhances Regulatory Certainty for Biotechnological Medicines 

Cofepris is implementing actions to support development of biotechnological and biosimilar medicines. A four-year strategic plan has been introduced to strengthen regulatory certainty across product lifecycle stages—from development and manufacturing to market authorization—supporting innovation and industry growth.

SAUDI ARABIA

SFDA Guideline on Advanced Therapy Medicinal Products (ATMPs) 

The SFDA has issued guidance defining and classifying ATMPs, including gene therapy, cell-based products, and combined ATMPs. Classification depends on whether a product meets criteria for a Gene Therapy Medicinal Product (GTMP), Cell-Based Medicinal Product (CBMP), or a combined ATMP.

Breakthrough Medicines Program 

Saudi Arabia’s Breakthrough Medicines Program aims to expedite the development and review of medicines addressing unmet medical needs for serious or life-threatening conditions. Participation is voluntary and emphasizes early engagement between developers and the SFDA. Designation requests may be submitted at the end of Phase 2 or later. SFDA provides tailored guidance based on development stage and data readiness.

Conditional Approval for New Human Medicines 

This framework outlines rules for granting conditional approval to new human medicines, including biologics, under specific obligations defined by SFDA. The legal basis derives from Chapter 3, Article 18 of the Registration Rules for Pharmaceutical, Herbal, and Health Product Manufacturers and their Products.