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

ASIA

Singapore

Guidance on Therapeutic Product Registration 

This guidance outlines the processes and requirements for submitting applications to register a therapeutic product or to request variations to an existing registration. A product registered under the Health Products Act (HPA) is defined by its brand name, formulation, dosage form, strength, indications, and dosing regimen.

Updates to ICH CTD, ACTD Checklists and MIV Submission Requirements 

The Health Sciences Authority (HSA) has updated multiple appendices, including: 

• Appendix 2A – NDA/GDA checklist (ICH CTD) 
• Appendix 2B – MAV checklist (ICH CTD) 
• Appendix 3A – NDA/GDA checklist (ACTD) 
• Appendix 3B – MAV checklist (ACTD) 
• Appendix 12 – MIV self-guided selection tool 

Guideline on PRISM Submission 

HSA revised Appendix 17, which details the procedures for: 

• Submitting new product applications 
• Filing variation applications 
• Responding to Input Requests (IR) 
• Withdrawing pending applications 

Draft Legislation on API Regulation 

HSA has released draft legislation for consultation addressing the regulation of active pharmaceutical ingredients (APIs). The aim is to develop a risk-based, internationally aligned framework. Licensing will be required for API importers and wholesalers under the Poisons Act, and manufacturers are encouraged to obtain GMP certification.

Pakistan

Draft Guidelines on Post‑Registration Variations 

DRAP has issued a second edition draft guideline on administrative, technical, and scientific variations to registered drug products. It explains variation categories, data requirements, and submission procedures for marketing authorization holders.

EUROPE

Formulation Approval for New Molecular Entities (NME) 

Local manufacturers must first submit NME applications under the NME Part 1 Pathway. MEC approval must then be attached to subsequent formulation approval applications.

REST OF WORLD (ROW)

Australia

Upcoming TGA Financial Deadlines 

Sponsors and manufacturing licence holders should be aware of financial deadlines: 

• ARTG entry invoices issued 1–15 August 2023; due 15 September 2023 
• Manufacturing licence fees due 1 October 2023 

Sponsors under the ACE Scheme must submit a $0 turnover declaration via TBS by 22 July 2023.

Turkey

Updated Guidance for GMP Audits of Overseas Facilities 

The updated guide for applying for GMP inspections of overseas production facilities was approved on 07.07.2023. Complete documentation is required to avoid delays.

Updates to “FAQ” and “Application Considerations” Documents 

The Turkish Medicines and Medical Devices Agency has updated both documents to reflect current regulatory practices.

Procedures for Service Fee Determination 

Revised principles for determining and updating service fees became effective on 01.07.2023.

Prescription System Improvements 

Enhancements to Turkey’s national electronic prescription system will take effect on 01.08.2023, ensuring branch verification is carried out exclusively through ÇKYS.

Saudi Arabia

Guideline on Braille Requirements 

This guideline explains Braille labeling requirements for human medicinal product packaging. For new products, it becomes effective three years after adoption; implementation becomes mandatory for all registered products five years after publication.

Updated Registration Rules for Manufacturers and Products 

Revised registration rules for pharmaceutical, herbal, and health product manufacturers were approved in accordance with regulatory requirements for periodic updates.

Canada

Master File Application Form Version 1.0.0 

Health Canada has released a new master file (MF) application form along with accompanying instructions.

Guidance on Administrative and Procedural Requirements for MFs 

The updated guidance includes the transition to an XML-based online system and outlines filing, processing, assessment, registration, updates, withdrawals, and closures for Type I–V master files.

Switzerland

Public Consultation on ICH Reflection Paper 

Swissmedic has opened a consultation on an ICH reflection paper regarding Real‑World Evidence (RWE) terminology. The deadline for comments is 30 September 2023.

HOMANT Asia Software for Notification‑Based Authorization 

Under the Complementary and Phytotherapeutic Products Ordinance, certain Asian medicinal products without indication may be authorized through notification. Swissmedic has released the HOMANT Asia electronic form for these submissions.

Guidance Document – Formal Requirements ZL000_00_020 

Swissmedic published this document to ensure consistent application of legal requirements and to guide applicants on structuring submissions for efficient processing.