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

ASIA

MALAYSIA (NPRA)

Declaration of Worldwide Registration Status for Generic Medicines

Malaysia now requires all new applications for Generic Medicines (Prescription – Full) to include a declaration of worldwide registration status (WWRS) using the designated template. This requirement took effect on 13 March 2023 and the template is available on the NPRA website under Industry → Generic Medicines → Downloadable Forms.

 Template-for-Declaration-of-Worldwide-Registration-Status-WWRS-E15

Approved Clinical Trial Import License & CTX Applications

NPRA has published updated resources on the process for obtaining Clinical Trial Import Licenses and Clinical Trial Exemptions (CTX).

Analysis of GMP Inspection Deficiencies

NPRA released an overview of deficiencies identified during GMP inspections conducted domestically and abroad. Of the 52 pharmaceutical facility inspections completed last year, two were judged unacceptable and resulted in regulatory action. Findings were categorized according to PIC/S GMP guidelines.

Guideline on Voluntary e-Labelling

NPRA has issued a guideline for implementing voluntary e-labelling for new drugs, biologics, and generic products containing scheduled poisons. E-labelling uses a QR code linked to NPRA’s QUEST3+ page displaying approved product information in PDF format.

JAPAN (PMDA)

Precautions for Handling Sustained-Release Preparations

PMDA has published guidance outlining risks associated with crushing sustained-release tablets, including potential changes in pharmacokinetics. Recommendations include the use of prescribing systems that help prevent inappropriate tablet manipulation.

SINGAPORE (HSA)

Import and Supply of Unregistered Therapeutic Products

Guidance is available on special access routes that allow import and supply of unregistered therapeutic products for patients with unmet medical needs. These provisions apply when treatment alternatives are unavailable.

Consignment Approvals for Unregistered Therapeutic Products

HSA published forms for named-patient and buffer-stock application types. These must be completed by the requesting healthcare professional and comply with the Health Products Act and associated regulations.

Industry Consultation on eCTD Implementation

HSA intends to introduce electronic Common Technical Document (eCTD) submissions for NDAs, generics, and DMF submissions. Adoption will be phased and voluntary at initial rollout.

PAKISTAN (DRAP)

Consolidated Notification on Regulatory Fees

DRAP has issued a consolidated notification outlining regulatory fees applicable to registration, renewal, and variation processes for drugs and medical devices.

Compliance Requirements in PIRIMS

DRAP has deployed the Pakistan Integrated Regulatory Information Management System (PIRIMS). All registration holders must update finished product specifications and validated testing methods. Regulatory fees may apply for delayed compliance.

REST OF THE WORLD (ROW)

SAUDI ARABIA (SFDA)

VICH GL39 – Specifications for New Veterinary Drugs

Saudi Arabia has adopted the revised VICH GL39 guideline covering test procedures and acceptance criteria for new veterinary drug substances and medicinal products of synthetic chemical origin.

CMC Requirements for Cell-Based Clinical Trial Applications

SFDA has issued detailed guidance on the Chemistry, Manufacturing, and Controls (CMC) documentation required for cell-based investigational products submitted under IND applications.

AUSTRALIA (TGA)

Consultation on Health Technology Assessment (HTA) Policy

The Australian government has initiated consultations to evaluate whether current HTA policies adequately support timely access to innovative medicines and ensure consistent supply.

Section 19A Application Form for Substitute Medicines

TGA has published the Section 19A application form for importing or supplying substitute medicines in cases of shortages. The form covers applicant details, justification for importation, packaging/labelling, and distribution plans.

BRAZIL (ANVISA)

New Subject Code for Impurity Qualification

ANVISA announced a new subject code (12224 – RDC 359/2020) for impurity qualification in line with ICH Q3A, Q3C, Q3D, and M7.

Three New Guides for Drug Registration

ANVISA has published three new guides supporting registration submissions for synthetic and semi-synthetic drugs:

• Guide 59/2023 – Complete development pathway 
• Guide 60/2023 – Abbreviated development pathway 
• Guide 61/2023 – Literature-based registration 

These guides reflect expectations under RDC 753/2022.

Guide for Import License Applications (LPCO)

ANVISA released updated guidance on submitting import license requests using the LPCO module in Siscomex, including detailed steps for electronic petitioning.

e-Notivisa Adverse Event Reporting Platform

ANVISA and MGISP have launched an experimental version of the e-Notivisa platform, enabling users to directly report product quality issues and adverse events to manufacturers and the agency.

SOUTH AFRICA (SAHPRA)

Quality and Bioequivalence Review Templates

SAHPRA published new templates for Quality and Bioequivalence Verified Review and Abridged Review. These templates apply to products already approved by recognized regulatory authorities.