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

ASIA

India

Mandatory Testing for Exported Cough Syrups

Beginning 1 June, India now requires manufacturers to obtain a Certificate of Analysis (CoA) from designated laboratories before exporting cough syrups. This policy follows incidents where syrups contaminated with ethylene glycol (EG) and diethylene glycol (DEG) were linked to child deaths, including cases associated with Indian-made products reported by the World Health Organization (WHO). Until now, cough syrups could be exported without documentation to verify compliance with EG and DEG limits.

PAKISTAN

Registration of Multiple Strength and Volume Pharmaceutical Products – Form 5F

The Drug Regulatory Authority of Pakistan (DRAP), based on recommendations from the Registration Board, has released guidance for filing registration applications for pharmaceutical products available in multiple strengths and fill volumes using Form‑5F.

Revised Requirements for Extension of Contract Manufacturing Permission

DRAP has also updated the data requirements for applications seeking extensions of contract manufacturing permissions for drugs with previously approved CTD dossiers.

PHILIPPINES

Updated Guidelines for License to Operate (LTO) Applications

The Philippine FDA continues to streamline processes for issuing marketing authorizations (MAs), including Licenses to Operate for manufacturers, distributors, traders, drug outlets, retailers, CROs and other health establishments. As part of this effort, the FDA is inviting one representative per organization to attend scheduled public hearings at the FDA Conference Hall in Alabang to discuss proposed policy updates.

REST OF WORLD (ROW)

SOUTH AFRICA

Renewal of Registration for Human and Veterinary Medicinal Products

SAHPRA has issued a guideline outlining current expectations for renewal applications for both human and veterinary medicines. It describes general requirements, processing procedures and detailed technical components for renewal submissions.

Adverse Drug Reaction and Quality Problem Reporting Form

SAHPRA has published document GLF‑CEM‑PV‑06A (Revision 3), which includes an updated form for reporting adverse drug reactions and quality-related issues.

BRAZIL

Expanded Rules for Clinical Testing in Pharmacies

ANVISA has approved new regulations significantly expanding the list of rapid tests that pharmacies may conduct—from two previously (glucose and COVID‑19) to nearly 50. The updated rule also introduces requirements related to technical procedures, data protection, and safety for all tissue testing facilities, including labs and collection centers. Facilities must comply with the new regulation by 10 November.

RWANDA

Revised Good Clinical Practice (GCP) Guidelines

Rwanda FDA has updated its GCP guidelines for clinical trials involving pharmaceuticals, biologicals, radiopharmaceuticals, herbal medicines and medical devices. Updates reflect ICH GCP principles, including risk‑based monitoring, multicenter trial considerations, and editorial adjustments aligned with current SOPs.

Updated Guidelines for Clinical Trial Applications

The revised guideline includes updated requirements for accepting GMP evidence for imported investigational products, essential elements for CTA acceptance, revised CTA templates, and requirements for amendments and renewals.

Guidelines on Safety and Vigilance of Medical Products & Health Technologies

These guidelines outline procedures, roles and reporting responsibilities for pharmacovigilance activities across public health programs, MAHs, academia, research institutions, technical representatives, health facilities and regulatory bodies. They also describe expedited reporting requirements, management of medication errors, product quality issues, unusual lack of efficacy and related communication and training needs.

ETHIOPIA

Guidance on Special Import Permits for Medical Products

The Ethiopian Food and Drug Authority has released guidance governing pre‑import and import permits for medical products required for public health emergencies, unmet medical needs, market shortages, clinical trials, health promotion, raw materials for manufacturing and health facility investment.