Pharma – Asia, S America, MENA, ROW Regulatory News – April 2025

AUSTRALIA

Product Information Safety Updates – April 2025

The Therapeutic Goods Administration (TGA) updates Product Information (PI) for medicines when new safety data emerges, ensuring health professionals and consumers have access to the latest safety details. This information is gathered through adverse event reports, literature reviews, regulatory collaborations, and on-going monitoring. PI updates may involve changes to indications, contraindications, precautions, or advice for special populations. Health professionals should be aware of these updates, as they may require modified prescribing practices or patient counselling. Major updates are often communicated through a Dear Health Care Professional Letter, and the TGA publishes monthly Medicines Safety Update (MSU) articles highlighting key changes.

More Medicines Begin Transition to Sole Ingredient Names Soon

From May 2025, medicine labels will transition from dual labelling showing both old and new active ingredient names to using only the new names. Dual labelling was implemented to help consumers and health professionals adjust to name changes. While most ingredient names completed this transition by April 2023, some continued with dual labelling until April 2025. Now, those medicines will begin displaying only the updated ingredient names.

Summit Pharmacy Pty Ltd Issued Infringement Notices for the Alleged Unlawful Manufacturing of Medicinal Cannabis Products

Summit Pharmacy Pty Ltd in Queensland was fined $75,120 by the Therapeutic Goods Administration (TGA) for allegedly manufacturing medicinal cannabis products unlawfully. Following an inspection in August 2024, it was found that the pharmacy had been producing cannabis oils in bulk, potentially violating the Therapeutic Goods Act 1989, which mandates proper registration or authorization for manufacturing therapeutic goods. The pharmacy paid the fines in February 2025. The TGA enforces compliance through infringement notices and legal actions. Individuals and businesses must ensure they follow regulatory guidelines when producing medicinal cannabis. Suspected non-compliance can be reported to the TGA.

Listed Medicines Requiring a Warning Statement

The Therapeutic Goods Administration (TGA) will begin targeted compliance reviews of selected listed medicines that must include a warning statement advising when to seek medical help for persistent diarrhoea. Sponsors are responsible for ensuring their medicines align with the Therapeutic Goods (Permissible Indications) Determination, including any mandatory warning statements for specific indications.

GMP Clearance compliance verification pathway: progress update (Published 4 April 2025)

The backlog of GMP Clearance CV applications is steadily decreasing after peaking at 2,547 in October 2024. Since then, there has been a ~10% overall reduction, driven by a ~23% decrease in Non-Sterile Active Pharmaceutical Ingredients (API) applications and a ~10% decrease in Sterile Finished Product applications. As new GMP evaluators complete training, further reductions are expected, with a focus shifting to Non-Sterile Finished Product applications. Updates on progress will continue through the Sponsor Information Dashboard and the TGA-Industry Working Group on GMP.

Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025

The Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, which began on 3 April 2025, updates the permissible indications and requirements for listed medicines, replacing the 2021 version. Changes include refined wording for indications related to circulation, organ health, and cystitis symptoms, as well as revised requirements on how bone disease references should be presented. The updates will soon be reflected in regulatory tables for listed medicines, ensuring consistency in ARTG entries. Other updates include terminology refinements, structural changes to regulatory tables, and reorganization of pregnancy- and sunscreen-related indications. Affected sponsors will be notified individually for major changes.

BRAZIL

Anvisa Holds Meeting With Drug Registration Holders on Updating the Reporting Strategy (Rpbrs)

Anvisa recently held a virtual meeting with drug registration holders (DRMs) on April 2, 2025, to clarify updates regarding the Periodic Benefit-Risk Assessment Reports (RPBRs). These reports, required under RDC 406/2020, help evaluate the safety profiles of registered medicines, ensuring compliance with Good Pharmacovigilance Practices and international standards (ICH Guide E2C(R2)). Anvisa also released a Portuguese translation of the E2C(R2) Guide and its Q&A section to support regulatory alignment. DRMs are responsible for continuously assessing benefit-risk profiles of medicines, including biological and advanced therapy products

Report on Prequalification Inspection of Synthetic Drugs

Anvisa will soon begin Pre-Qualification Inspections (IPQs) for manufacturers of synthetic medicines, as outlined in RDC 823/2023. This optimized assessment tool evaluates whether companies can consistently meet registration and post-registration requirements for medicines. Theprequalification process applies to drugs still in development or those awaiting regulatory approval. Anvisa has also released POP-F-ANVISA-221, which provides detailed instructions and forms related to IPQs. These inspections aim to increase efficiency in regulatory processes while encouraging technical development in the pharmaceutical industry, ensuring high-quality medicines for the Brazilian population.

EGYPT

The Head of the Egyptian Drug Authority is Following Up on Efforts to Withdraw Expired Medicines (Published on 16 April 2025)

The Egyptian Drug Authority (EDA), led by Dr. Ali El-Ghamrawy, held a meeting to follow up on the withdrawal of expired medications. The discussion focused on regulatory procedures, ensuring safe disposal, and strengthening drug circulation control. The initiative, launched in December 2024, aims to protect public health by preventing the risks of circulating unsuitable medications and reinforcing confidence in drug quality. The EDA emphasized joint coordination with trade unions and professional bodies to achieve a stable pharmaceutical system. The meeting included key officials and external representatives supporting the initiative. The EDA is optimistic about the plan’s success and encourages collaboration among stakeholders to ensure effective implementation.

The Head of the Drug Authority Receives the Ceo of Makers to Discuss Developing the Local Manufacturing of Medical Supplies(Published on 17 April 2025)

The Egyptian Drug Authority (EDA), led by Dr. Ali El-Ghamrawy, held a meeting with Makers’ leadership to discuss medical supplies manufacturing and localization efforts. Makers representatives presented their projects and contributions to Egypt’s healthcare sector. Dr. El-Ghamrawy reaffirmed the EDA’s commitment to collaboration, supporting local manufacturing to strengthen the national economy and improve access to safe and effective medical supplies. The meeting emphasized harmonizing efforts between the EDA and industry partners to enhance Egypt’s pharmaceutical market. Key officials from the EDA and industry attended the discussion, reinforcing the ongoing partnership between regulators and manufacturers.

The Drug Authority reviews the importance of obtaining WHO accreditation in the field of medicine

The Egyptian Drug Authority (EDA) has made significant strides in international regulatory standards, securing WHO Level 3 Maturity approval for both vaccines and pharmaceuticals, making Egypt the first African country to achieve this. With continued government backing, Egypt’s pharmaceutical sector is set to expand into global markets, attract foreign investments, and enhance local production. This milestone strengthens Egypt’s leadership in healthcare while reinforcing its commitment to safe, effective medical products.

INDIA

Notice Regarding Change in Monograph Titles and Synonyms in the Indian Pharmacopoeia

The Indian Pharmacopoeia Commission (IPC) has proposed changes to monograph titles and synonyms in the upcoming edition of the Indian Pharmacopoeia (IP) 2026, expected in December 2025 and effective from July 2026. Manufacturers and stakeholders must evaluate the impact of these changes on existing products, update labels, obtain regulatory approvals, and revise artwork to ensure compliance. Early adoption is encouraged, allowing stakeholders to secure approvals beforehand. Regulatory authorities are advised to facilitate necessary license updates. During the transition period, both current and proposed titles will be considered synonyms, but once IP 2026 takes effect, compliance with new monograph titles will be mandatory.

INDONESIA

Bpom Socializes Atmp Regulations to Improve Product Safety and Quality (Published on 21 April 2025)

BPOM has introduced Regulation Number 8 of 2025 to enhance guidelines for Advanced Therapy Medicinal Products (ATMP), replacing the 2020 regulation. Announced by BPOM Head Taruna Ikraron April 21, 2025, the new rule aims to strengthen safety, efficacy, and quality standards for ATMPs, which are increasingly used in healthcare, especially in cancer therapy. The regulation ensures proper distribution and manufacturing standards, supporting local ATMP production to reduce reliance on imports. BPOM has also recognized five stem cell processing facilities with Good Manufacturing Practice (CPOB) certificates, fostering investment and technological development in Indonesia.

MALAYSIA

Submission of Rimup for Evaluation by the Pharmacovigilance Section, Pkkk

Starting April 2025, all RiMUP submissions for evaluation by the Pharmacovigilance Section must be made through the QUEST 3+ system, replacing the previous manual process. However, the existing evaluation procedure for products registered after January 1, 2014, remains unchanged under the Centre of Product and Cosmetic Evaluation (PPPK).

For Pharmacovigilance Section evaluations, the following new variation labels must be used:

• MiV-PA3(PV) – For pharmaceutical or biologic products
• MiV-PA2(PV) – For natural products with therapeutic claims and health supplements with disease risk reduction claims

After submission, an email should be sent to rimup@npra.gov.my for notification. Further details can be found in the updated guidelines

Outcome of Gvp Inspection Voluntary Phase (2023-2024): Preliminary Key Findings & Trends

The GVP Inspection ensures that Product Registration Holders (PRHs) and related parties comply with Malaysian Guidelines on Good Pharmacovigilance Practices (GVP) and post-registration safety requirements set by NPRA. The voluntary phase, initiated as part of progressive implementation, helps identify gaps before full enforcement. The main findings relate to Quality Management Systems (QMS), Adverse Drug Reactions (ADRs), and Risk Management, with additional concerns in ADR collection and collation, particularly among local manufacturers. NPRA commends PRHs for their strong commitment to the process.