Pharma – Asia, MENA, ROW Regulatory News – June 2025

BRAZIL

Anvisa Warns About Very Rare Adverse Event Associated With Semaglutide That Can Lead to Vision Loss

Anvisa has issued a warning about a very rare but serious side effect—sudden vision loss—linked to semaglutide-based medications like Ozempic®, Rybelsus®, and Wegovy®. This reaction, called NAION, may be irreversible and requires immediate medical attention if symptoms like blurred or sudden vision loss occur. Following this, from June 23, 2025, these drugs can only be sold with a retained medical prescription as per new regulations (RDC 973/2025 and IN 360/2025). Health professionals are urged to inform patients and report any adverse effects to Brazil’s VigiMed system.

Anvisa Orders Seizure of Batches of Counterfeit Medicines

Anvisa has ordered the seizure of two counterfeit medicines: Rybelsus (lot M088499) and Ofev (lot 681522), after confirming that these batches were not manufactured by their respective companies, Novo Nordisk and Boehringer Ingelheim. Rybelsus is used to treat type 2 diabetes, while Ofev is prescribed for serious lung conditions like idiopathic pulmonary fibrosis and systemic sclerosis-associated interstitial lung disease.

Guidance for the Public and Health Professionals:

• Buy only from regulated pharmacies, with full packaging and a valid invoice.
• Do not use any medicine suspected of being counterfeit.
• Verify authenticity with the product’s official manufacturer.
• Report cases immediately:
  • Health professionals: via the Notivisa system.
  • Patients: through the FalaBR platform.

CHINA

Announcement on Broadened Use of eCTD Format for Drug Applications

The National Medical Products Administration (NPMA) of China has announced an expansion in the scope of Electronic Common Technical Document (eCTD) implementation, effective from January 27, 2025. This expansion includes a wider range of drug clinical trial applications and marketing authorization applications for various classes of chemical drugs and biological products.

Applicants are required to prepare and submit their dossiers electronically in the eCTD format, following the current technical requirements. Online submission is strongly encouraged to improve efficiency and support the “Internet + Drug Regulation” initiative. Detailed operational guidelines are available on the official website of the Center for Drug Evaluation, facilitating a smooth transition to the expanded eCTD submission process.

Regulatory Requirements for the 2025 Chinese Pharmacopeia

The National Medical Products Administration (NMPA) has announced that the 2025 Edition of the Pharmacopoeia of the People’s Republic of China will come into effect on October 1, 2025. This edition establishes updated legal and technical standards that all drug manufacturers and marketing authorization holders must follow for drug research, production, distribution, and supervision.

Key points include the requirement for compliance with the new pharmacopoeia standards by all marketed drugs and registration applications, the phased replacement or continuation of previous standards depending on drug inclusion, and the obligation for marketing authorization holders to review and update drug registration standards accordingly. The announcement also addresses management of changes in drug formulation and packaging, transitional provisions for drug names, and responsibilities of regulatory authorities to ensure effective implementation and oversight.

Natasvir Phosphate Capsules Receive Marketing Approval from China NMPA

Sunshine Lake Pharma Co., Ltd.’s Class 1 innovative drug, Netanasvir Phosphate Capsules, has recently been approved for marketing by the China National Medical Products Administration (NMPA). This medication is intended for use in combination with Encofosbuvir Tablets to treat adult patients with chronic hepatitis C virus (HCV) genotypes 1, 2, 3, or 6. It is suitable for both treatment-naïve patients and those previously treated with interferon, including patients with compensated liver cirrhosis. The approval of this drug offers a new therapeutic option for patients affected by these HCV genotypes.

INDIA

Mandatory Use of ONDLS Portal for WHO-GMP Certification

The UGS Standard Control Organization under the CDSCO (Central Drugs Standard Control Organization) has issued a directive to all State and UT Drugs Controllers regarding the mandatory online submission of applications for the WHO-GMP Certificate of Pharmaceutical Product (COPP) through the ONDLS portal, developed by CDAC.

From 15th July 2025, only online applications will be accepted for WHO-GMP (COPP) and Manufacturing Licenses. Physical file submissions will no longer be entertained. This move aims to streamline and digitize the licensing process across India.

The circular also provides contact details for technical support related to the ONDLS portal and instructs all zonal and sub-zonal offices not to accept hard copies after the mentioned deadline.

INDONESIA

New Bpom Regulation for Verification of Drug and Drug Ingredients Analysis Methods

BPOM has issued Regulation No. 10 of 2025 to standardize and strengthen the verification of analytical methods used in drug and drug substance testing. Effective from May 2, 2025, the guideline ensures that laboratory procedures are scientifically validated, reliable, and suited to actual lab conditions. It supports drug registration, aligns with Good Manufacturing Practices (CPOB), and enhances Indonesia’s drug quality monitoring. The regulation outlines four key method categories, with detailed criteria provided in an attached guideline. Stakeholders are urged to apply the regulation consistently.

Bpom Tightens Supervision of Certain Drugs That Are Often Abused

BPOM has enacted Regulation No. 12 of 2025 to strengthen control over Certain Drugs Often Abused (OOT), replacing the 2019 version. Effective May 2, 2025, the regulation mandates Good Manufacturing and Distribution Practices for drugs like tramadol, trihexyphenidyl, chlorpromazine, amitriptyline, haloperidol, dextromethorphan, and now ketamine, which was added due to rising misuse.

The regulation requires:

• Detailed transaction records at pharmaceutical facilities
• Mandatory reporting of lost OOT drugs
• Risk management plans to prevent diversion
• Stricter oversight of ketamine distribution, which surged from 134K vials in 2022 to 440K in 2024

Seven provinces, including Lampung and Bali, were flagged for ketamine distribution irregularities. The regulation also emphasizes public education and stakeholder collaboration to combat drug abuse.

LEBANON

The Ministry of Public Health Launches the “The Good Pharmacovigilance Practices Guideline”

The Lebanese Ministry of Public Health has officially launched its first National Guide for Good Pharmacovigilance Practices, marking a major step toward strengthening drug safety and regulatory oversight in Lebanon. The guide, developed in line with EU and Arab GVP frameworks, sets clear standards for all stakeholders—from manufacturers to healthcare providers—to ensure the safe and effective use of medicines, hospitalization, and medicine, highlighting the need for quality assurance amid past challenges with counterfeit and unregulated drugs. He also announced upcoming initiatives, including a central laboratory for medicine testing and a public awareness campaign on drug safety.

The guide mandates:

• Appointment of pharmacovigilance coordinators and officers
• Mandatory reporting systems
• Training and awareness initiatives
• Tools like the LASA list and the Excipients with Known Effects list

MALAYSIA

Submission of RiMUP for Evaluation by the Pharmacovigilance Section – Single Variation Only

Since April 2025, all RiMUP submissions for evaluation by the Pharmacovigilance Section must be made through the QUEST 3+ system. Submissions should be made as a single variation only—bundling with other variation types is not accepted, as evaluations are conducted by different officers. Applicants must ensure that all other variations are submitted and approved before submitting the RiMUP to avoid delays.

Mandatory Screening Package for New Drug Products and Biologics – Effective 16 June 2025

The National Pharmaceutical Regulatory Agency (NPRA) has introduced a dedicated Screening Package for New Drug Products and Biologics to streamline the submission process and ensure dossier completeness. The package provides clear guidance and mandatory forms, including a cover letter, screening checklist, applicant declarations, and compliance forms, tailored to different submission pathways.

Effective from 16 June 2025, all new registration applications must include the Screening Package to facilitate an efficient regulatory review. Applicants are encouraged to use the package to meet regulatory requirements and improve submission quality.

PHILIPPINES

Lifting of Interim Extension for License to Operate (LTO) Renewal Application Period – FDA Advisory No. 2025-0015-A

The FDA announces the immediate lifting of the interim extension previously granted under FDA Advisory No. 2025-0095 regarding the renewal application period for Licenses to Operate (LTO). Effective immediately, all LTO renewal applications must adhere to the original prescribed renewal period of ninety (90) calendar days prior to license expiration, as outlined in Administrative Order 2024-0015. Stakeholders are advised to comply strictly with this reinstated timeline for efficient regulatory processing.

Guidelines on the Re-issuance of Order of Payment and Temporary Suspension of New FDA Fees and Charges

The Food and Drug Administration (FDA) of the Philippines issues guidelines concerning the re-issuance of Orders of Payment following the temporary suspension of Administrative Order (AO) No. 2024-0016, which implements the new schedule of fees and charges. Effective 10 June 2025, Department Circular No. 2025-0240 suspends AO No. 2024-0016 for sixty (60) working days to address operational concerns and stakeholder feedback. During this suspension, fees will revert to the previous schedule under AO No. 50, s. 2001. Stakeholders with unpaid applications filed under AO No. 2024-0016 may request re-issuance of Orders of Payment via specified email channels corresponding to their application types. Partial payments or underpayments will still be processed under AO No. 2024-0016 fees. The FDA will continue system upgrades and stakeholder consultations during this period and will announce further updates via official platforms. Stakeholders are advised to follow the guidelines closely for the smooth processing of their applications.

Update on the Temporary Suspension of Administrative Order No. 2024-0016 on FDA Fees and Charges

The Food and Drug Administration (FDA) announces that it will release the Implementing Circular regarding the temporary suspension of Administrative Order No. 2024-0016, titled “Implementing Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration,” on or before 10 June 2025. All stakeholders are advised to monitor the official FDA website regularly for the latest updates. The FDA reaffirms its commitment to safeguarding public health by ensuring the safety, efficacy, purity, and quality of health products, while continuously improving regulatory processes and service delivery.

SOUTH AFRICA

The Impact of Pharmacovigilance on Public Safety: A SAHPRA Mandate

SAHPRA plays a vital role in ensuring medicine safety through its robust pharmacovigilance system, which involves tracking, assessing, and preventing adverse drug effects. From managing risks linked to COVID-19 vaccines and valproate to deregistering pholcodine-containing medicines over life-threatening allergic reactions, SAHPRA acts swiftly to protect the public. It mandates strict safety systems for manufacturers, promotes stakeholder collaboration, and leverages digital tools and AI to enhance safety monitoring. Despite challenges like underreporting, SAHPRA continues to strengthen its regulatory framework, aiming to make health products safer for all South Africans.

SAHPRA Alerts the Public About Fake License Holders

SAHPRA has issued a strong warning to the public about the use of fake licences by individuals and companies falsely claiming to be SAHPRA-authorised. These fraudulent activities, particularly among cannabis dispensaries in shopping malls, pose serious health and safety risks. SAHPRA clarified that licences issued for cannabis cultivation and export do not permit retail dispensary operations.

To combat this, SAHPRA is developing a barcode-based verification system and launching a public awareness campaign. The public is urged to verify licences via SAHPRA’s official website and report any suspicious activity through their hotline or complaint portal. CEO Dr. Boitumelo Semete-Makokotlela condemned the unethical conduct and affirmed SAHPRA’s commitment to protecting public health through strict regulatory oversight

SAHPRA Undergoes Training To Strengthen Its Regulatory Capabilities

SAHPRA recently completed a three-day training program hosted by the Egyptian Drug Authority (EDA) in Cairo to strengthen its capabilities in achieving the WHO Global Benchmarking Tool (GBT) Maturity Level 3 (ML3) for medicines regulation. This initiative, part of a 2023 Memorandum of Understanding between the two agencies, focused on enhancing SAHPRA’s regulatory governance, transparency, and performance monitoring. The training, led by EDA’s Centre for Continuing Professional Development, benefited multiple SAHPRA departments and marked a key step in advancing regulatory excellence across the African continent