Asia-Pacific Roundup: India’s CDSCO adopts prior intimation system to accelerate study startup

India’s Central Drugs Standard Control Organisation (CDSCO) has implemented the previously proposed “prior intimation” system to accelerate the initiation of certain clinical trials.

CDSCO proposed the system in January 2026 as part of an amendment to the New Drugs and Clinical Trial Rules, 2019. The system is designed to allow companies to start some bioavailability and bioequivalence (BA/BE) studies after notifying authorities of their plans, rather than applying and waiting for permission to initiate the assessments. CDSCO proposed implementing the system 90 days after publication; that date passed last week.

Companies can now use Form CT-05 in the Sugam portal to indicate their intent to run studies under the simplified process. The process is open to single-dose, two-period, two-sequence, two-treatment BA/BE studies of oral dosage forms in healthy adult volunteers. Studies must be conducted for export purposes to be eligible for the system.

CDSCO clarified the criteria in a frequently asked questions document. Cytotoxic, hormone, narcotic, and psychotropic substances are not eligible, nor are drugs with a narrow therapeutic index or highly variable pharmacokinetics. All oral dosage forms are eligible, including liquid formulations and modified-, sustained-, and extended-release formulations.

The medicine must be approved in India, the US, the EU, Japan, Australia, Canada, or the UK. Studies started under the pathway can only enroll up to 18 people.

The ethics committee will review the protocol and other documents submitted via the prior intimation pathway, upload the approval letter in the online portal, and maintain records of the assessment and authorization process. The central licensing authority can review the records at any time. CDSCO named registration renewals and inspections as examples of when authorities could review the records.

Acknowledgments of prior intimation will remain valid for one year, unless canceled or suspended by regulators. Sponsors can request an extension of the validity period in writing. The central licensing authority may grant the request in exceptional circumstances when it is satisfied that an extension is needed. Sponsors cannot make changes after receiving acknowledgment of prior intimation.

CDSCO Notice; FAQ

Singapore and Japan move toward GMP inspection reliance arrangements

Authorities in Singapore and Japan have agreed to enhance bilateral cooperation in regulating health products.

Singapore's Health Sciences Authority (HSA) and Japan’s Ministry of Health, Labour and Welfare signed a memorandum of cooperation last week. HSA called the pact a significant milestone that “reinforces the shared commitment to advancing regulatory excellence through international collaboration to benefit pharmaceutical manufacturers.”

The agreement seeks to promote cooperation in key areas of mutual interest, including collaboration in facilitating reliance for health product and good manufacturing practice (GMP) inspections. HSA said GMP reliance is a key focus.

By enabling mutual reliance for GMP certificates and inspection outcomes, HSA said authorities could remove an average of three duplicative inspections per year and improve access to medicines by up to 6 months. Authorities will continue to adhere to strict safety standards as processes are streamlined, HSA said.

The agreement provides Singapore and Japan with a formal mechanism for collaboration across the lifecycle. HSA named clinical trial and product reviews, registration and reliance, manufacturing, and post-market oversight as areas across the lifecycle with which it could collaborate with its counterpart in Japan. The collaboration could cover medicines; cell, tissue, and gene therapy products; and medical devices.

Press Release

Philippine FDA seeks feedback on good review and submission practices

The Philippine Food and Drug Administration (FDA) has published draft guidance on good registration, review, and submission practices for pharmaceutical products.

FDA is introducing the good registration management (GRM) framework to promote “an efficient and well-managed registration process for pharmaceutical products.” GRM supports regulatory convergence by aligning FDA processes with internationally recognized best practices. The framework entails the coordinated implementation of good review practices (GRevP) and good submission practices (GSubP).

To institutionalize GRM in the Philippines, FDA plans to adopt World Health Organization guidelines on GRevP. FDA said the guidelines will support evidence-based reviews of approval applications and make its decisions more consistent and predictable. The agency plans to implement GSubP in line with standards issued by organizations, including the Asia-Pacific Economic Cooperation committee. 

FDA will integrate key elements of GRevP into its review system by “establishing clear policies and defined responsibilities, utilizing standardized assessment templates, ensuring peer review and quality checks, applying scientific advice and reliance pathways, [and] implementing transparency measures.” GRevP will apply to facility licensing, clinical trial authorizations, drug approvals, and other processes.

The agency expects all applicants to adopt and comply with existing internationally recognized guidelines on GSubP. Applicants, reviewers, and decision-makers will receive FDA training and capacity building to support GRM implementation.

FDA is accepting feedback on the proposals until 22 May.

Draft Guidance

Indian Pharmacopoeia Commission inks deal to strengthen drug standards

The Indian Pharmacopoeia Commission (IPC) has signed a memorandum of understanding with India’s National Institute of Pharmaceutical Education and Research (NIPER), Hajipur, to promote collaboration on pharmaceutical standards, regulatory science, and patient safety.

The organizations plan to collaborate on “impurity profiling and safety correlation of drugs, development and validation of advanced analytical methods, and establishment of quality control protocols,” IPC said.

Other goals include developing reference standards for complex biologics, biosimilars, and emerging therapeutic products, including cell and gene therapies. IPC plans to include the standards in the Indian Pharmacopoeia.

The pact was one of three agreements involving IPC and NIPER Hajipur that were signed last week. IPC also partnered with the Pharmaceuticals and Medical Devices Bureau of India (PMBI) on a generic drug scheme. PMBI will send randomly selected batches of medicines provided through the scheme to IPC for quality testing.

NIPER Hajipur formed a collaboration with Boehringer Ingelheim. Under the agreement, Boehringer will give researchers access to its open science platform and help build research capacity at NIPER Hajipur. The partners aim to generate early-stage proof-of-concept data to support preclinical development.

Press Release, More

After complaints, New Zealand’s Medsafe finds Sandoz patches meet standards

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has found hormone replacement therapy patches sold by Sandoz meet quality standards.

Medsafe asked PHF Science to test three batches of Estradot bought from a licensed wholesaler in the New Zealand supply chain. The batches covered the three patch strengths that were the subject of patient complaints about efficacy and patch adhesion. Medsafe received the most complaints in October and November, but has continued to periodically receive new complaints.

The tests measured the amount of active ingredient in each patch and assessed variability in the content between patches. Medsafe also assessed whether the formulations had deteriorated and the rate of drug release from the patches. All the batches met the specifications. Medsafe is still waiting on the results of tests performed by Australia’s Therapeutic Goods Administration.

PHF Science’s findings add to the evidence that the Estradot patches meet quality standards. Sandoz previously shared test results and other information to support the quality of its products. Medsafe has consistently found no evidence of a quality defect or any indication that a batch is faulty or warrants a recall.

The agency is continuing to investigate the complaints by reviewing changes made since it approved the patches and assessing whether the timing is associated with patients raising concerns.

Medsafe Notice