Asia-Pacific Roundup: Japan’s PMDA shares guidance on assuring safety in generic bioequivalence studies
The Pharmaceuticals and Medical Devices Agency (PMDA) has published advice on ensuring the safety of healthy adult participants in Japanese bioequivalence studies.
Published as part of the “early considerations” series, the newly translated document is PMDA’s response to increased development of products associated with psychiatric and neurological symptoms. Sponsors dealing with risks such as suicidal ideation and suicide attempts, interstitial lung disease, and bone marrow depression have asked PMDA about safety management systems for bioequivalence studies.
The questions reflect a gap in PMDA’s guidance. An existing guideline covers safety assurance for trials that administer active substances to humans for the first time. Yet no corresponding guidance has been established for the development of generic drugs.
PMDA has filled the gap with a general approach based on discussions in bioequivalence consultations conducted to date. The document is designed to help sponsors plan human bioequivalence studies and protect study participants.
The agency divided the document between general advice on safety management systems and guidance on handling specific safety risks. PMDA’s general advice section covers study design topics, including the enrollment, dosing, and discontinuation criteria. Based on data for the innovator drug, sponsors should establish criteria for identifying participants who should discontinue treatment on safety grounds.
PMDA’s general advice also covers operational considerations. Sponsors should work with physicians who “respond appropriately” to adverse events that could lead to serious outcomes. Other requirements include coordination structures that shape how study sites share information and contact emergency transport destinations.
The other section of the document features advice for managing specific adverse events, including thromboembolism, QT prolongation, and psychiatric symptoms. Sponsors developing generic copies of drugs with psychiatric symptoms should implement appropriate safety management systems, PMDA said. PMDA’s psychiatric symptom advice addresses assessments of suicide-related events.
Pakistan’s DRAP starts consultation into quality control for sterile single-use syringes
The Drug Regulatory Authority of Pakistan (DRAP) is seeking industry feedback on plans to create an internationally harmonized technical framework for the quality of sterile single-use syringes.
DRAP’s draft guidance will establish a framework for quality evaluation, design verification, and quality control testing of sterile single-use syringes in Pakistan. The draft applies to regulatory authorities and notified laboratories, which should adopt the harmonized testing standards as the official benchmark for inspections and post-marketing surveillance testing.
The document also applies to manufacturers and importers of the devices. DRAP wants companies to use the framework to align their quality management systems, raw material procurement policies, internal quality control batch release protocols, and laboratory testing.
Registration holders will need to identify and comply with the complete set of specific technical standards applicable to each of their registered products. Affected companies must submit formal lists of applicable standards within 60 days of DRAP issuing the guidelines.
All registration holders must only use biocompatible and medical-grade materials, including packaging materials, for each component of imported and locally manufactured syringes. DRAP prohibits the use of non-biocompatible or non-medical grade materials, as well as materials that do not comply with relevant standards for medical devices.
The agency framed the guidance as a response to a “reported surge of HIV cases associated with unsafe medical practices, particularly the alleged reuse of contaminated syringes.” The surge triggered the creation of a working group. DRAP’s Medical Device Board met in August to discuss implementing the working group’s decisions.
DRAP, which published the draft on 7 October, is accepting comments for 10 days.
Indian government seeks feedback on planned expansion of advertising restrictions
India’s Ministry of Health and Family Welfare has proposed expanding the restrictions on advertising prescription-only medicines.
Current Indian law prohibits pharmaceutical manufacturers from advertising Schedule H, Schedule H1, and Schedule X drugs without prior permission from the government. However, the law lacks an explicit ban on the promotion of such medicines by organizations licensed to sell and distribute drugs. The gap in the rules leaves retailers and wholesalers free to advertise prescription drugs.
Government officials plan to close the gap by imposing a blanket ban. The draft legislative update states: “No advertisement of the drugs specified in Schedule H, Schedule H1, or Schedule X shall be made except with the previous sanction of the Central Government.”
The proposal is intended to strengthen regulatory oversight of the supply chain, discourage unauthorized promotion of prescription medicines, and reduce risks associated with inappropriate self-medication. By delivering those benefits, the government expects to reinforce safeguards covering certain antibiotics, psychotropic medicines, and other prescription-only drugs that require appropriate medical supervision.
Officials published the proposal 11 months after India’s Drugs Consultative Committee received reports of “widespread and unchecked advertisement of prescription-only and potent drugs including life-saving injectables, antibiotics, hormonal preparations, psychotropic substances, anti-cancer drugs, and narcotic drugs.” The reports triggered a discussion at the Drugs Technical Advisory Board and the draft proposal.
The proposal is open for comment for 30 days.
Press Release, Gazette Notification
2D data matrix barcode and serialization requirements take effect in Pakistan
All registered drug products manufactured locally or imported into Pakistan must carry 2D data matrix barcodes after the implementation of new rules on 9 October.
DRAP mandated the implementation of a 2D barcode and serialization framework in June and gave the industry four months to comply. In July, the agency shared guidelines on implementing GS1 data matrix barcodes and a national track and trace system for registered pharmaceutical products in Pakistan.
The day before the four-month transition period ended, DRAP published a circular restating the deadline for complying with the requirements. The agency outlined actions it has taken to help the industry prepare, including “technical sessions, workshops, and nationwide hands-on training roadshows.”
Manufacturers and importers “shall adhere strictly to the technical parameters defined” in the rules, DRAP said. Companies that fail to comply with the label requirements could face legal action, the agency added.
DRAP clarified that batches produced locally or imported with a manufacturing date before 9 October are exempt from the labeling requirements. Products made before the end of the transition period can be imported, distributed, and sold without 2D data matrix barcodes.
Other News:
The International Medical Device Regulators Forum (IMDRF) has approved the Thai Food and Drug Administration’s (FDA) application for affiliate membership. Affiliate members engage with IMDRF but do not qualify as official observers, a rank reserved for regulators with perceived contribution or value to the forum. The Thai FDA joins its Indian counterpart as an affiliate member. IMDRF Statement
The Therapeutic Goods Administration (TGA) has issued fines totaling AU$126,720 ($88,350) to two companies and five individuals for alleged breaches of Australian legislation. The fines include three notices to individuals accused of importing Mounjaro, Eli Lilly’s GLP-1/GIP receptor agonist. TGA fined companies for advertising drugs, including ketamine, and for importing melatonin. TGA Notice
China has nominated Song Li as a candidate to replace Tedros Adhanom Ghebreyesus as director-general of the World Health Organization (WHO). Confirming the news at a press conference, a spokesperson for China said the nomination showed the country’s “firm support for multilateralism and the WHO.” The US withdrew from WHO in January. Indonesia is among the other countries to nominate people. Transcript
DRAP is seeking feedback on draft revisions to its guidelines on drug manufacturing licenses. The text covers license applications and renewals, as well as other post-license variations. DRAP is accepting feedback for 15 days. DRAP Notice
