Asia-Pacific Roundup: Access Consortium updates generic drug work-sharing procedures

Access Consortium has updated the operational procedures for its Generic Medicines Work-Sharing Initiative (GMWSI) with information on the acceptance of foreign comparator products in bioequivalence studies.

The consortium, which features the regulatory agencies of Australia and Singapore, established GMWSI to enable its five members to collaborate on the assessment of generic medicine applications and then reach their own decisions. Access published its original operational procedures in 2016 and has now updated the document three times.

Version 4.0 of the document features two new appendices. The first appendix provides information on the acceptability of foreign comparator products from Europe, the US, Canada, Australia, Singapore, Switzerland, and Great Britain in each of the jurisdictions involved in the consortium.

For each jurisdiction, the consortium has listed whether a comparator product is potentially acceptable and discussed the key criteria and exceptions. The comparator products are potentially acceptable in most of the jurisdictions.

The exception is the UK. Because of the post-Brexit situation in Northern Ireland, comparator products from countries including the US and Canada are not accepted in the UK. European Union requirements apply to applications submitted to the UK. The comparators are accepted in Great Britain, which covers England, Scotland, and Wales but not Northern Ireland.

As well as giving a yes/no answer on whether a comparator is potentially acceptable, Access has shared specific details on when a foreign product can be used. For example, Australia will accept a comparator from Europe when it is identical in appearance to the local product, is made by the same global company and has similar dissolution. That acceptance only applies to oral dosage forms. Developers of other types of dosage forms should contact the Therapeutic Goods Administration (TGA) to discuss acceptability.

The second appendix outlines the current regulatory requirements regarding the acceptance of foreign comparator products. The table lists the positions of each of the five agencies in the consortium on a range of attributes of drug substances and drug products.

For example, the table explains that Singapore's Health Sciences Authority only permits foreign products with the property “narrow therapeutic index/critical dose” if they were made at the same drug product manufacturing site as the Singapore reference product.

TGA Notice

India’s CDSCO clarifies position on acceptance of foreign toxicity data

India’s Central Drugs Standard Control Organization (CDSCO) has published the conclusions of its review of the toxicity study requirements for new drugs, subsequent new drugs, and fixed-dose combinations.

After reviewing the requirements, CDSCO reiterated points from the New Drugs and Clinical Trials Rules, 2019. The rules require repeated dose toxicity studies for new drugs; however, there may be exceptions.

Unless there are specific concerns, companies do not need to run toxicity studies in India “where the data on animal toxicity as per the specifications of clause 2 has been submitted and the same has been considered by the regulatory authority of the country which had earlier approved the drug.” The rules also state overseas animal toxicity data may be accepted on a case-by-case basis.

Quoting those parts of the rules, CDSCO said “it has been decided to accept already generated preclinical toxicity data for review in the case of drug substance and drug product, based on the quality of data and the credentials of the laboratory where such data has been generated.”

CDSCO said the animal toxicity data needed for “new claims namely indications, dosage, dosage form or route of administration etc. should be determined on [a] case by case basis.” The agency will consider the nature of the new claims, the mechanism of action and existing nonclinical data in the approved claim when assessing a case. “Relevant” safety data will be needed when using unapproved excipients.

CDSCO Notice

Hong Kong approves revised GMP guide, sets July 2025 implementation date

Hong Kong’s Pharmacy and Poisons Board (PPBHK) has approved updates to the good manufacturing (GMP) guide that will take effect on 1 July 2025.

The revised GMP guide consists of two documents: the Hong Kong guide to GMP for the secondary packaging of pharmaceutical products; and Part I, Part II, and the annexes of the Pharmaceutical Inspection Co-Operation Scheme’s (PIC/S) guide to GMP practice for medicinal products. PPBHK has published both documents ahead of their implementation in 2025.

PPBHK’s secondary packaging guide describes standards and requirements for licensed pharmaceutical manufacturers that are only authorized to conduct secondary packaging. The board will also use the text as the standard for the inspection and licensing of premises for secondary packaging of pharmaceutical products.

The guide describes the requirements in nine areas, including pharmaceutical quality system, personnel and secondary packaging. The secondary packaging section starts with general points, such as the need for labels applied to containers to be “clear, unambiguous and in the company’s agreed format,” before covering specific issues related to starting materials, operations, and rejected and returned goods.

PPBHK is also implementing the PIC/S’ guide to GMP and published the documents on its website. The implementation covers the two parts to the guide and the 20 annexes that the scheme published in 2023. The addition of annex 16, which covers certification by the authorized person and batch release, is the main change to the earlier version of the guide.

GMP Notice

IPC tells Indian manufacturers to prepare for elemental impurity changes

The Indian Pharmacopoeia Commission (IPC) has told manufacturers to start changing their quality systems to ensure compliance with incoming revisions to elemental impurities standards.

IPC said the new statement is a continuation of a notice it published in August 2023. Seeking to clarify its position, the commission said it is in the process of adopting elemental impurity requirements in line with other pharmacopeia. The International Council for Harmonisation has revised the limits of some elementals in Q3D (R2), and IPC is reflecting the updates in its own documents.

The commission is also working to replace tests on heavy metals in individual monographs to make elemental impurity requirements mandatory from the next edition of the Indian Pharmacopoeia in 2026.

“In view of the above, all concerned are once again requested to start working on required necessary changes in the quality systems for their readiness and ensuring compliance with the revised elemental impurities standards for the IP 2026,” IPC said.

IPC Notice

TGA reiterates ban on weight-loss drug ads as Novo nears Wegovy launch

TGA has reminded businesses and media outlets that it is unlawful to publicly advertise prescription-only medicines, including weight-loss drugs. The regulator published the notice the day before revealing Novo Nordisk is set to launch its weight-loss drug Wegovy in Australia.

Over the past six months, TGA has fined companies more than AU$ 300,000 ($193,000) in relation to the advertising of weight-loss drugs. The agency also issued three infringement notices to a media outlet for alleged unlawful advertising of prescription-only medicinal cannabis on its lifestyle website. TGA’s latest notice states media outlets are responsible for ensuring content does not promote prescription drugs.

One day after issuing the warning, TGA said Novo will launch its semaglutide weight-loss brand Wegovy in Australia in early August. Ozempic, the diabetes brand, is already available in Australia but TGA has been discouraging off-label use as it manages a shortage of the drug. TGA said it is unclear how the Wegovy launch will affect the availability of Ozempic.

TGA Notice, More

Asia-Pacific Roundup: Access Consortium updates generic drug work-sharing procedures

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