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

ASIA

Singapore

Guidance on therapeutic product registration in Singapore

This guidance document describes the procedures and requirements for submitting an application to register a therapeutic product, or to make a variation application to a registered therapeutic product. A therapeutic product registered under the HPA is specific to the product with respect to its: proprietary or brand name; pharmaceutical formulation; pharmaceutical dosage form (i.e. physical presentation) and strength; and indication(s) and dosing regimen.

HSA updates ICH CTD, ACTD checklists, submission requirements specific for MIV applications

Health Sciences Authority updates Appendix 2A – Application checklist for NDA and GDA (ICH CTD), Appendix 2B – Application checklist for MAV (ICH CTD), Appendix 3A – Application checklist for NDA and GDA (ACTD), Appendix 3B – Application checklist for MAV (ACTD), Appendix 12 – MIV self-guided tool for post-approval Variation Selection.

Guideline on prism submission

HSA updates appendix 17, Guideline on prism submission. This appendix primarily describes the processes for: Submitting a new product application, submitting a variation product application, responding to Input Request (IR) from HAS, Withdrawing a pending application.

Singapore’s HSA seeks feedback on draft active pharmaceutical ingredient legislation

Singapore’s Health Sciences Authority (HSA) has released draft legislation on the regulation of active pharmaceutical ingredients (APIs) for consultation. The legislation is intended to create “a fit-for-purpose and risk-based licensing framework” that is aligned with international standards. Currently, Singapore regulates APIs under the Poisons Act 1938 and Medicines Act 1975. The legislation requires licensing of importers and wholesalers under the Poisons Act and encourages manufacturers to apply for voluntary good manufacturing practice (GMP) certification under the Medicines Act. HSA said it has identified a need for a new approach.

Pakistan

Stakeholders Comments are invited on Draft Guidelines for Post-Registration Variation of Drugs

DRAP has rolled out a draft for the second edition of its guidelines on procedure and data requirement for post registration variation of drugs. These Guidelines are intended to assist manufacturers and importers to incorporate variations in their product to account administrative changes, technical and scientific progress, or to improve or introduce additional safeguards. This guideline is intended to provide information for submission of post-registration variation application by the registrations / marketing authorization holders of drug products. It includes categories of variations and the required documentation & procedures for submission of an application for a particular variation.

Sri Lanka

Formulation Approval Applications for New Molecular Entities (NME)

 All the local Manufacturers are hereby informed that if the molecule is a NME, such application should be submitted to NME Part 1 Pathway before applying for formulation approvals. After getting MEC approval for particular NME, those approvals should be attached to the formulation approval applications.

ROW

Australia

Sponsors and manufacturers reminded about upcoming financial deadlines

For the sponsor of a product in the Australian Register of Therapeutic Goods (ARTG) or the holder of a manufacturing license, there are some important financial deadlines approaching regarding your TGA account. Invoices for active ARTG entries will be issued from 1-15 August 2023. The legislated due date for full payment is 15 September 2023.The legislated due date for full payment of manufacturing licenses is 1 October 2023. For sponsors of ARTG entries which are exempt from annual charges under the Annual Charge Exemption (ACE) Scheme, applicant should make a ‘Declaration of $0 Turnover’ online via the TGA Business Services (TBS) portal- external site by 22 July 2023.

Turkey

Guidelines for Applications for GMP Audits of Overseas Production Facilities

The Guide on Applications for GMP Audits of Overseas Production Facilities published on the Official website of our Institution on 30.12.2022 has been updated. The said Guide, which came into force with the Authority’s Approval dated 07.07.2023 and numbered E-24931227-000-14046, is included in the annex of the announcement. It is important that all applications made to the Pharmaceutical Inspection Department, Overseas Facility Inspections Application and Follow-up Unit are made in full with the necessary documents specified in the Guide, in order not to waste time.

“Frequently Asked Questions” and “Matters to be Considered in Applications

In order to ensure that the licensing processes carried out by the Pharmaceutical Regulatory Department of our Agency and the processes carried out in licensed products are made more efficient for both our Agency and our stakeholders; “Frequently Asked Questions” and “Matters to be Considered in Applications” documents were updated and published in line with current legislation and practices.

Procedures and Principles Regarding the Determination and Update of the Service Fees of the Turkish Medicines and Medical Devices Agency

The Procedures and Principles for Determining and Updating the Service Fees of the Turkish Medicines and Medical Devices Agency, which determines the procedures and principles for the determination and updating of the price tariffs for the services offered by the Turkish Medicines and Medical Devices Agency, have been approved to enter into force as of 01.07.2023 with the Approvals of the Ministry.

About the regulation to be made in the recipe system

The Prescription System has been developed in order to create prescriptions by physicians on the electronic environment, to view the created prescriptions instantly by pharmacists, to give the drugs they need to the patients, and to carry out the processes in an integrated manner with the Social Security Institution (SGK), which is the reimbursement institution. The system has been opened to the use of health institutions to cover all prescriptions and is used by health professionals throughout the country. In order not to disrupt the delivery of health services and to prevent possible abuses, improvements have been completed to ensure that branch control transactions are carried out only through ÇKYS in the system, and the work to be done in this regard will be put into effect on 01.08.2023.

Saudi Arabia

Guideline on the Braille Requirements for Labeling Information of Medicinal Products for Human Use

This guidance interprets the requirements for Braille on the packaging of human medicinal products to be available in formats for blind and partially sighted people. For new medicinal products seeking marketing authorization, the final version of this document is effective after 3 years following the adoption date of the guideline. After 5 years of publishing the final version of this document, the implementation is mandatory for all registered products.

The Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and their Products

the Registration Committee of Manufacturers of Pharmaceuticals and their Products has approved the updated the Registration rules of Pharmaceutical, Herbal and Health Product Manufacturers and their Products, based on Article (20/4) of the Implementing Regulations of the Law of Pharmaceutical and Herbal Establishments and Products, which stated that the registration committees must conduct the update tasks for the Registration rules of Pharmaceutical and Herbal Products.

Canada

Master File Application Form (Version 1.0.0)

Health Canada published Master File Application Form (Version 1.0.0). This also includes instructions to be followed for the application form.

Guidance on procedures and administrative requirements for master files

The revised guidance document is administrative in nature. It was revised to include the change to an online web-based XML application process. This guidance document provides MF-related definitions, information on filing requirements, processing and assessment procedures for Type I to V MFs. It also outlines the registration requirements for new MFs, as well as other MF transactions including administrative changes, updates, withdrawals and closures.

Switzerland

Public Consultation on ICH Reflection Paper launched in Switzerland

Swissmedic launches the Public Consultation on a Reflection Paper on Real-World Evidence Terminology (RWE) of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), with a deadline of 30 September 2023 for comments. This Reflection Paper was endorsed by the ICH Assembly in June 2023. The Reflection Paper presents opportunities for development of new ICH Guidelines and is herewith submitted for public consultation.

Software HOMANT Asia for the authorization based on a notification (notification procedure) of Asian medicinal products without indication

The Complementary and Phytotherapeutic Products Ordinance (KPTPO; SR 812.212.24) provides for Asian medicinal products without indication a marketing authorization based on a notification. The single notifications must be submitted in the form prescribed by Swissmedic according to article 41 of the KPTPO. Swissmedic provides a corresponding electronic form and has developed the HOMANT Asia software for this purpose.

Guidance document- Formal requirements ZL000_00_020

Swissmedic uses this guidance document first and foremost as a resource for applying the legal provisions in a uniform and equitable manner. The publication of this document provides transparency concerning how applications should be structured so that they can be processed efficiently and completed in accordance with Swissmedic’s practices and systems. This document also takes into account all publications on this subject in the Swissmedic Journal in recent years.