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

ASIA

Malaysia

Guideline for Facilitated Registration Pathway (FRP)

NPRA revised Guideline for Facilitated Registration Pathway (FRP). The revised pathway includes registration schemes that may be considered for abbreviated and verification review as well as the inclusion of additional Drug Control Authority (DCA) reference agencies. The scope is broadened to include generic medicines in addition to new drug products and biologics (including CGTP). Eligibility criteria, documents required and the timeline for registration process are revised according to type of review. Dossier checklists and process flowcharts were included.

Pakistan

DRAP invites Comments on Draft Guideline for Storage and Destruction of Substandard-Falsified (SF) and recalled Therapeutic Goods

The Drug Regulatory Authority of Pakistan (DRAP) has drafted a guideline on the storage and destruction of recalled therapeutic goods, which are medicines, medical devices, and health products that do not meet the quality standards or are deliberately misrepresented. The guideline aims to provide a framework for the safe and effective management of such goods, from their identification and reporting to their disposal and documentation.

DRAP Added New eService for Online Data Submission for Registration of Pharmaceutical and Biological Product

The Drug Regulatory Authority of Pakistan (DRAP) is pleased to announce the addition of a new e-service for online regulatory data submission registration/marketing authorization of human drugs for local manufacturing, import and export. The Licensing Operations of all [pharmaceutical and biological manufacturers are already enabled through the same plate form. This e-service is part of the transformation strategy of the Drug Regulatory Authority of Pakistan which aim to ensure the quality, safety and efficacy of therapeutic goods in Pakistan. The e-service requires applicants to submit their data in a standardized format.

Singapore

HSA Singapore Designated as WHO-Listed Authority for its Medicines Regulatory System

The Health Sciences Authority (HSA) has been designated by the World Health Organization (WHO) as a WHO-Listed Authority (WLA) on 26 October 2023 for its medicines regulatory system. This means that HSA is now recognized globally as operating at an advanced level of regulatory performance, ensuring that medicines in Singapore meet high safety, efficacy and quality standards.  In January 2022, HSA had attained the WHO Maturity Level 4[1] based on our operational efficiency. The subsequent assessment for WLA included a thorough review of the quality of regulatory assessments, the scientific soundness of the decision-making and their consistent implementation. WHO’s comprehensive assessment of HSA’s core functions and operations, conducted by a team of 10 international assessors and WHO officials, took place from October 2022 to March 2023.

China

NMPA becomes the applicant for PIC/S

In late September 2023, the National Medical Products Administration (NMPA) submitted the formal application to the Pharmaceutical Inspection Co-operation Scheme (PIC/S). On Nov 8, 2023, PIC/S sent a letter to NMPA confirming the applicant status. Following this confirmation, NMPA will strengthen communication and cooperation with the PIC/S, promote itself to become a full member of PIC/S, and take this opportunity to continuously improve the country’s drug inspection system and standards, to constantly enhance its drug inspection quality management system and to steadily promote the development of its inspectors’ team, so as to modernize the national drug regulation in China.

ROW

South Africa

Clinical Trials Committee and Submission Dates for 2024

This communication is for Stakeholders to be aware of the South African Health Products Regulatory Authority (SAHPRA) Clinical Trials Committee meeting dates and the submission dates for the year of 2024. Applicants are advised to submit clinical trial applications before the due date. Applications submitted after the due date will not be accepted.

Australia

Global event promotes side effect reporting

The Therapeutic Goods Administration (TGA) teams up annually with medicines safety organizations and regulators around the world to promote #MedSafetyWeek. This year’s event runs from 6 to 12 November. MedSafetyWeek promotes reporting of medicine side effects (known as ‘adverse events’) by consumers and health professionals. Such adverse event reports are an important part of identifying any emerging problems and help us to keep medicines safe (an activity known as pharmacovigilance).

Update to listed medicine ingredients in October 2023

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2023- external site, which commenced on 25 October 2023. This determination replaces the previous instrument, the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2023.

New medicine adverse event search for sponsors

TGA has launched a new search functionality in the Adverse Event Management System (AEMS)- external site web portal.  Sponsor can now access TGA-held adverse event reports relevant to the medicines and biologicals in a self-serve manner. Sponsor can: search for reports, filter results using multiple data attributes, download de-identified Public Case Detail (PCD) and Case Line Listing (CLL) reports for inclusion into their own pharmacovigilance systems.

Mexico

Cofepris offers regulatory certainty for the development of biotechnological medicines

The Federal Commission for the Protection against Sanitary Risks (Cofepris) launches actions to provide regulatory certainty to companies in the biotechnology pharmaceutical sector, which represents medical innovations and productive development in the Mexican market. With the aim of promoting the development, manufacturing and marketing of biotechnological and biosimilars in our country, this health authority has developed a work plan with a four-year horizon, considering the life cycle of the pharmaceutical product.

Saudi Arabia

SFDA Guideline on Classification of Advanced Therapy Medicinal Products

This guideline provides definitions for Advanced Therapy Medicinal Product (ATMP) in Saudi Arabia. The aim of ATMP Guideline on classification of ATMPs is to provide guidance on the ATMP definitions, as well as on the interpretation of key concepts of the definition of gene therapy medicinal products and cell based medicinal products, and combined advanced therapy medicinal products. ATMP classification will be based on the evaluation of whether a given product fulfills one of the definitions of Gene Therapy Medicinal Product (GTMP) or Cell Based Medicinal Product (CBMP), and whether the product fulfills the definition of a combined ATMP or not.

Breakthrough medicines program

Breakthrough medicines program aims to facilitate and accelerate development and review of new drugs that address unmet medical need in the treatment of serious or life-threatening conditions. The program is voluntary and based on enhanced interaction and early dialogue with drug developers, to optimise development plans and speed up evaluation and ensure that promising medicines are available as soon as it can be concluded that the medicines’ benefits justify their risks. Under the breakthrough medicine program, the designation request may submitted by the end of phase 2 or at any time after. The SFDA will assess the application and provide a guidance based on the stage of drug development and provided data at submission time.

Conditional Approval for new human medicines

This document lays down rules on the granting of Conditional Approval for new human medicines, including biologics, subject to specific obligations in accordance with SFDA’s requirements. 1.2. Legal basis The legal basis for the conditional approval is Chapter 3, Article 18 of the Registration Rules of Pharmaceutical, Herbal, and Health Product Manufacturers and their products Guideline.