Asia-Pacific Roundup: PMDA website promotes bringing products to Japanese market

The Pharmaceuticals and Medical Devices Agency (PMDA) has created a website to centralize documents on why and how companies should develop products for the Japanese market.

PMDA has recently embarked on a push to engage with overseas companies, providing the help and resources they need to bring their products to market in Japan. The initiative includes the creation of the regulatory agency’s first office in the US and now the launch of a website that covers what drug and device companies need to do to access the Japanese market.

The opening section of the English-language website outlines why Japan is an attractive market for drug developers, explains PMDA’s support for venture companies, and details the country’s medical device approval process. Across the files, PMDA presents Japan as a large market with predictable, internationally harmonized processes that can act as a gateway to the rest of Asia.

The website also provides links to additional information on PMDA and drug and device regulation in Japan. One section outlines PMDA regulations and services, covering topics such as drug and medical device reviews, good practice inspections, and postmarketing safety measures. Other sections link to lists of products approved in Japan, information on the accreditation of foreign manufacturers, and the websites of public organizations and industry associations.

Finally, the site provides information on PMDA’s “advanced efforts,” a set of initiatives such as its “early consideration” scheme, and work to coordinate its offices to examine issues that cut across institutional boundaries. The early consideration scheme, which provides information on specific topics such as developing pulmonary arterial hypertension drugs, has ramped up recently. PMDA has published five English-language documents since December, for a total of seven.

PMDA Website

India extends FDC submission deadline, moves to stop exports of unapproved combo

India’s Central Drugs Standard Control Organization (CDSCO) has given companies more time to submit fixed-dose combination (FDC) filings after “most of the firms” missed the original deadline.

CDSCO has worked for years to remove from the Indian market irrational drug combinations that lack approval from the central licensing authority. Last year, the agency gave companies that held state licenses for the affected FDCs before October 2012 until 7 November 2024 to submit applications to run a Phase IV trial. The agency ordered the studies to address gaps in evidence on certain FDCs.

The revised deadline is the latest in a series of extensions CDSCO has granted after FDC manufacturers have failed to comply with its requests. The agency said it will recommend “appropriate regulatory action” against companies that miss the latest deadline.

CDSCO sent the letter the day after India’s Ministry of Health and Family Welfare published a press release about the export of unapproved combination drugs containing the synthetic opioid tapentadol and the muscle relaxant carisoprodol. The US Food and Drug Administration (FDA) warned against combining opioids and muscle relaxants after finding the combination can cause serious side effects such as breathing problems and deaths.

According to the ministry, Aveo Pharmaceuticals has been exporting tapentadol/carisoprodol combinations to certain West African countries. Both drugs are approved in India, but they are not authorized for use together. CDSCO audited Aveo last month and issued an order to stop all operations at the site. Regulators seized ingredients and finished products and withdrew export and manufacturing licenses granted for any combination of tapentadol and carisoprodol.

The Indian agency is updating the export checklist to require a product registration certificate from the importing country or CDSCO approval to export medicines. The ministry said the update “will address the root cause of the problem and settle the issue once for all.”

CDSCO Notice, Press Release

Medsafe updates mpox vaccine communication over pericarditis cases

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has updated its information on the safety of Bavarian Nordic’s mpox vaccine Jynneos.

Medsafe first commented on the safety of pox vaccination in March 2023 after receiving two reports of pericarditis that suggested a link to the vaccine. Medsafe responded by monitoring the safety concern and asking healthcare professionals to report any cases of pericarditis in patients who had been vaccinated against mpox.

Last week, Medsafe updated its original communication. Jynneos received provisional approval in New Zealand in September. The New Zealand Pharmacovigilance Database now includes five suspected adverse reaction reports of pericarditis following Jynneos vaccination. Jynneos’ US prescribing information lists myocarditis, inflammation of the heart muscle, as a side effect of the vaccine.

Medsafe is now working with Bavarian Nordic to update the datasheet. The update will add advice about the need for vaccine recipients to seek immediate medical attention if they develop symptoms such as chest pain. Patients who present with signs of pericarditis should be urgently referred to specialists for diagnosis and treatment.

Medsafe Notice

CDSCO pushes for uniform implementation of rules on delayed-release oral medicines

CDSCO has told regional drugs controllers to ensure the uniform implementation of rules on modified or sustained-release drug tablets and capsules.

Under the New Drugs and Clinical Trials Rules, 2019, modified or sustained release forms of a drug and novel delivery systems of any centrally approved drugs are always classed as new drugs. India’s Drugs Consultative Committee (DCC) discussed the implementation of the rules for gastro-resistant and delayed-release dosage forms in June.

The DCC recommended that a circular be published for the drugs controllers in all India’s states and union territories. CDSCO followed through on that recommendation last week, sending a circular stating that dosage forms should always be deemed to be new drugs. The circular, which is intended to ensure the uniform implementation of the rules, applies to enteric-coated tablets and capsules.

CDSCO Notice

India updates SUGAM portal to support more applications for changes to clinical trials

CDSCO has updated the SUGAM portal to support submissions to add clinical trial sites and change the principal investigator for studies of biological products.

SUGAM is an online portal that enables companies to carry out a range of regulatory activities in India. CDSCO has expanded the portal over the years to support a wider range of regulatory services. The latest update supports changes to the information on studies of vaccines and recombinant DNA products.

CDSCO is asking companies to submit applications via SUGAM, including a checklist of documents and the ethics committee's approval. Applicants can consider their requests to be approved unless CDSCO objects within 30 days.

CDSCO Notice

Other news

PMDA has explained an update to Keytruda’s Japanese label. The label was updated in late January to include “pancreatic exocrine insufficiency” as an adverse reaction. Because the reaction is the first of its type on a Japanese prescription drug label, PMDA provided more information in its monthly safety report. PMDA Report

Asia-Pacific Roundup: PMDA website promotes bringing products to Japanese market

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