Asia-Pacific Roundup: Australia’s TGA sets out transition to newer version of PIC/S Guide to GMP

Australia’s Therapeutic Goods Administration (TGA) has established a transition period for the newer version of the PIC/S Guide to Good Manufacturing Practice (GMP).

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) document provides international standards to support the removal of trade barriers, ensure the quality of drug products and active ingredients and promote uniformity in licensing decisions. Australia updated its rules to bring version 16 of the guide into effect early in June but established a transition period for one of the fundamental changes to the new edition.

Manufacturers have until 3 September to assess and plan for any changes they need to make to comply with Annex 16, a new addition to the guide that covers certification by the authorized person and batch release.

Previously, TGA guidance on release for supply was based on the EU GMP Annex 16. At first, PIC/S did not make the EU annex part of its guide because it believed the document was EU-specific and challenging to transpose. The PIC/S guide was focused on the manufacture of medicinal products, not on the import and distribution topics covered by the EU annex. Still, the body later decided to adopt the text.

Australian manufacturers have already been following advice substantially similar to Annex 16 in the PIC/S Guide to GMP; however, according to TGA, some manufacturers may need to implement or modify processes to provide improved or more detailed evidence of compliance.

The agency has listed the new requirements and commented on what they mean for manufacturers in a related guide. The document also covers the impact of the changes PIC/S has made to Annex 13, an existing section of the guide that applies to the manufacture of investigational products.

PIC/S updated Annex 13 based on the EU Clinical Trials Regulation. The revisions are intended to keep PIC/S and EU GMP standards equivalent to facilitate the exchange and use of information concerning the manufacture of medicinal products. TGA regards the changes to Annex 13 as minor and, as such, began enforcing them without a transition period early in June.

TGA Notice, TGA Guide

Medsafe updates overview of therapeutic product regulation in New Zealand

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has updated its overview of therapeutic product regulation. Version 2.0 of the document aligns the text with changes made since Medsafe published the first edition in 2014.

Medsafe has updated the links to the legislation governing the regulation of therapeutic products in New Zealand and made other changes to the text. The document remains focused on describing different types of therapeutic products, how they are categorized, and the regulatory framework that applies to them.

The section on the types of therapeutic products now features a reference to the Medicinal Cannabis Agency, a body that became operational in 2020 to administer regulations passed in 2019. “Medicinal cannabis products that have been verified as meeting the minimum quality standard may be supplied as unapproved medicines under the scheme if prescribed by a medical practitioner,” according to the guide.

Medsafe’s overview of the regulatory framework for therapeutic products provides information about the key control elements in New Zealand’s legislation and the types of goods they affect. The guidelines outline controls on availability, market entry and exit, quality, access and information. Medsafe links to other GRTPNZ documents for more information by directing readers to a text focused on new medicine applications.

Medsafe Guidelines

DRAP finds unacceptable ethylene glycol levels in Pakistan amid flurry of alerts

The Drug Regulatory Authority of Pakistan (DRAP) has issued notices about two drugs that contain unacceptable levels of ethylene glycol (EG), the cough syrup contaminant linked to the deaths of hundreds of children.

DRAP has worked to prevent EG-contaminated products from reaching patients by detecting it in both finished products and raw materials. The latest notice covers batches of two finished syrup drug products, Torax and Zonid, that contain unacceptable levels of EG. DRAP named Siza International and Bloom Pharmaceuticals as the manufacturers.

The agency told the manufacturers to recall the affected batches immediately. DRAP included the drugs in a broader recall notice with four other products. DRAP found the other products were substandard for reasons unrelated to EG and told their manufacturers to begin recalls.

Officials published the recall notice on the same day as an alert about 10 spurious products, including capsules of Velosef with labels listing GSK as the manufacturer. DRAP said spurious or falsified drugs may contain harmful levels of toxic substances. The agency also posted an alert about an illegal manufacturing site that was allegedly making a banned hormone for enhancing milk production.

DRAP Notice

Japan’s PMDA contributes to push to improve immunomodulator dose selection

A researcher at Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has co-authored a paper on improving the selection of immunomodulator doses in first-in-human (FIH) clinical trials.

Currently, the choice of dose of immunostimulators, a type of immunomodulator associated with acute toxicity, is based primarily on identifying the minimum anticipated biological effect level. However, that approach can result in the use of subtherapeutic doses. Starting dosing too low makes dose escalation a long and expensive process.

An initiative involving PMDA, Novartis, Pfizer and others attempted to improve the process by surveying the industry about dose selection strategies and developing case studies. The work led to a revised decision tree, which the collaborators presented in a paper in Clinical Pharmacology & Therapeutics.

“This approach facilitates a more refined recommendation of FIH dose selection for immunomodulators, allowing for a nuanced consideration of their mechanisms of action and the associated risk-to-benefit ratio, among other factors,” the authors wrote.

Paper

Other news:

TGA seeks volunteers to help improve its web content on software and artificial intelligence medical devices. The agency wants to improve the “structure and content” of the information on its website. To inform the public about the changes, TGA asks the medical devices industry, health software developers, and consumers to share input on its design concepts in one-hour usability sessions. TGA Notice

The newly appointed Indian Union Minister, Ministry of Health and Family Welfare, has set out the health goals the recently elected government wants to achieve in its first 100 days. Work to raise awareness of non-communicable diseases, an area of concern for the new minister, is part of the strategy. Press Release, More

Asia-Pacific Roundup: Australia’s TGA sets out transition to newer version of PIC/S Guide to GMP

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