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

Pakistan

Pakistan’s DRAP encourages users to update pharmacovigilance app after recent revisions

The Drug Regulatory Authority of Pakistan (DRAP) has asked users of its Med Safety App to update the software to take advantage of new features and bug fixes implemented by the developer. DRAP published a notice about a “significant update” implemented by its counterpart in the UK. DRAP told users the MHRA update allows its National Pharmacovigilance Centre “to ask specific questions relating to a patient’s report based on the information provided.”

Important Notice to Pharmaceutical / Biological Manufacturers and Importers

DRAP has deployed an online application management system namely, Pakistan Integrated Regulatory Information Management System (PIRIMS) for processing of regulatory information related to licensing, registration and inspections of pharmaceutical and biological drugs. All the Registration Holders of pharmaceutical and biological drug products are directed to update the finished product specifications and validated testing procedures i.e. Pharmacopoeial or in case of non-availability in any pharmacopeia, Innovator / Manufacturer’s Specification,  in the corresponding product profile / details in the PIRIMS at http://pirims.dra.gov.pk. The portal  to perform the above-said activity will remain accessible for thirty days after publication of this notice and afterwards, no request shall be entertained.

Pakistan’s DRAP starts urgent recall of ethylene glycol-tainted products

The Drug Regulatory Authority of Pakistan (DRAP) is urgently recalling seven products manufactured by Davis Pharmaceutical Laboratories because of the discovery of ethylene glycol at “unacceptable levels.” Earlier this month, Gambia’s Medical Control Agency issued a safety alert about a batch of KOF Relief Syrup, a product that contains a combination of ingredients designed to relieve dry coughs and other cold symptoms. Gambia, where tens of children died last year after using cough syrups, found the batch contained unacceptable levels of the contaminant ethylene glycol. The batch was made by Davis Pharmaceutical Laboratories, a manufacturer based in Islamabad, Pakistan. DRAP’s recall covers KOF Relief Syrup, and six other products made using the same sources of glycerin and propylene glycol, the likely causes of the contamination. Four of the products, including KOF Relief Syrup, were manufactured for export.

Stakeholders Comments are invited on Draft Amendments in the Drugs (Research) Rules, 1978

The Drug Regulatory Authority of Pakistan (DRAP) has issued a proposal to amend the current version of the Drugs (Research) Rules, 1978. These draft amendments are herby notified seeking comments from stakeholders. Stakeholders can submit their comments within 14 (fourteen) days of the publication of this Notification using prescribed format, via email to aamar.latif@dra.gov.pk, or can be posted at mailing address, Additional Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Malaysia

Malaysia’s NPRA creates declaration of worldwide registration status for generic medicines

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has created a template for declaring the worldwide registration status of generic medicines in its Quest online submission system. The template asks users to provide information including the name of the product, its application status, and the application type and registration number in the registered country. If the application type is the decentralized procedure, NPRA wants the applicant to include the reference member state on the form. The template supports the provision of information about multiple products. NPRA has designed the template for use with all new applications for prescription generic medicines. The creation of the template follows NPRA’s publication of a guide to uploading bioequivalence study reports to the Quest 3+ online portal and its updating of the guidance notes for active pharmaceutical ingredient information for product registration.

Egypt

Guideline for Registration of Biosimilar Products in Egypt

This guideline is a replacement of the published guideline for registration of biosimilar products in Egypt (2020) to keep up with the recent international guidelines on evaluation of biosimilar and should be read in conjunction with regulatory guide for mechanisms, procedures and rules of implementing decree of Egyptian Drug authority’s president No. 343/2021 and Procedures for Registration of Biological products through Reliance pathways.

Egyptian Guidelines on CTD Quality Module for Human Pharmaceuticals

This guidance aims to provide applicants with information and documents required for preparation of the CTD Quality Module for human pharmaceutical products. It aims also to inform the applicants with the adopted references and guidelines used in the evaluation of CTD Quality Module in a way that does not contradict with any of the Egyptian published regulations, legislations, decisions & registration ministerial decrees. This guidance applies for any human pharmaceutical product submitted for evaluation of CTD Quality Module according to different Ministerial Decrees and Technical Committee Decisions.

Philippines

Philippine FDA shares guidelines on regulatory reliance for the conduct of clinical trials

The Philippine Food and Drug Administration (FDA) has posted guidelines about relying on the decisions of other regulatory agencies to facilitate the evaluation of clinical trial applications. The document sets out the rules for sponsors, contract research organizations, investigators and research ethics committees that are involved in all phases of multi-region clinical trials. Under the guidance, drug developers can receive clearance to run some clinical trials under the abridged regulatory pathway. The pathway enables FDA to solely or partially base its decision on the assessment of a reference drug regulatory agency (RDRAs) such as the European Medicines Agency and US Food and Drug Administration. The Philippine regulatory agency has designated 14 of its peers as RDRAs.

Uruguay

Uruguay launches ‘Health Intelligence Node’ to aid region

In March Uruguay’s government announced the creation of a “Health Intelligence Node” (Nodo de Inteligencia Sanitaria) that would facilitate information exchange among regional health authorities, citing “the need to generate health intelligence to support decision-making in health; the importance of making explicit the tacit knowledge of the organizations and a regional mandate to strengthen the horizontal cooperation between countries.”

Indonesia

Fourth amendment to regulation of the head of drug control agency and food concerning criteria and procedure of drug registration

Several provisions regarding the types of changes, requirements, and completeness of variation registration documents in Appendix XVI to the Regulation of the Head of the Drug and Food Control Agency Number 24 of 2017 concerning Criteria and Procedures for Drug Registration amended so that it becomes as stated in the Appendix which is an integral part of this Agency Regulations.

Australia

TGA queries on big fee increases for upcoming financial year

Australia’s Therapeutic Goods Administration (TGA) has proposed double-digit increases to its annual charges to cover inflation and recoup investment in its digital transformation and move to purpose-built facilities. In a public consultation, TGA has outlined plans to apply a 5.2% indexation factor to fees and charges to cover most of its rising costs — inflation in Australia is 7% — while still incentivizing the agency to find savings and efficiencies. However, the 5.2% increase is not the only change. TGA’s government funding for some activities requires it to further increase fees to recoup the investment over the next five years. Specifically, the government provided AU$23.3 million ($16.1 million) to complete TGA’s digital and business transformation and enable full implementation of the unique device identifier system and is paying the regulator’s landlord AU$4.85 million annually for 15 years to cover the fit out of its laboratory.

Korea

Analytical Methods for the Determination of Mutagenic Impurities in Drug Substances or Drug Products

This document is intended to provide pharmaceutical industry with the information about the analysis methods for the determination of mutagenic impurities in drug substances or drug products. The analysis methods in this document were developed and validated in the research studies funded by MFDS. Before adapting the analysis methods to the test site, verify or validate the methods with suitable procedures.The analysis methods could be changed according to the further research studies, and different from the policy of the MFDS.

Uganda

Guidelines on submission of documentation for registration1 of a pharmaceutical product for human use

These guidelines are intended to provide guidance to applicants to prepare product dossiers in CTD format for submission to NDA. These guidelines are developed in accordance with the National Drug Policy and Authority Act Cap 206. These guidelines apply to product dossiers for chemical pharmaceutical products containing existing APIs of synthetic or and new APIs. These guidelines do not apply to vaccines, biosimilars, biotherapeutics and herbal preparations.

South Africa

Adverse Drug Reactions And Quality Problem Reporting Form

SAPHRA published Adverse Drug Reactions and Quality Problem Reporting Form – for both public and private sector and includes herbal products.

Tanzania

Reminder to all sponsors and principal investigators to register and update clinical trial information on the national clinical trial registry

The Tanzania Medicines and Medical Devices Authority (TMDA) would like to remind all Principal Investigators (PIs) and Sponsors whose trials have been authorized to be conducted in Tanzania to ensure that their trials are registered in the National Registry established by the Authority not later than twenty-one (21) days following the enrolment of the first study participant. Those that have already registered, whenever necessary, are required to provide an update on the status of the trial until its completion. This directive is in line with the requirements prescribed in part III of Regulation 7 of the Tanzania Medicines and Medical Devices Clinical Trials Regulation of 2013. (Clinical Trials Control) and is among the conditions stated in the approval letter issued by the Authority in accordance with the Tanzania Medicines and Medical Devices Act, Cap. 219.