Asia-Pacific Roundup: Pakistan floats guideline changes on GCP inspections and more

The Drug Regulatory Authority of Pakistan (DRAP) is seeking feedback on three documents, sounding out stakeholders on planned changes to its guidelines on clinical trial inspections, recalls and establishing pharmaceutical units, the first editions of the three documents between 2021 and 2023.

The most significant changes are proposed for the guidelines on the inspection of good clinical practices (GCPs) and the recall of defective therapeutic goods to align with international standards and best practices, address feedback, and incorporate the lessons of workshops.

The agency plans to add sections on the risk-based selection of clinical trials for inspection and the reporting of GCP findings and create multiple new subsections. The new section on the selection of studies for inspection lists seven criteria, including whether vulnerable populations may be part of the trial. In multi-center studies, DRAP will prioritize inspecting sites with more participants and report more deviations and adverse events.

A new section on reporting inspection results outlines the process and timeline for communicating findings. If the inspectors find a failing that “needs to be resolved at a time or is critical observation and can harm wellbeing of trial participants,” the panel will immediately inform the chairman of the clinical studies committee. DRAP is also seeking feedback on largely rewritten text for multiple existing sections.

The proposed changes to the product recall guideline are less extensive. DRAP seeks to delete sections on terminating recalls, mock recalls, its role, establishment inspections and the rapid alert system. One discussion of mock recalls has been shortened and appears elsewhere.

DRAP also seeks feedback on changes to the recall procedure. The agency is considering giving drug companies more time to start recalls and physically remove products from the market. Currently, firms should start Class I recalls within 24 hours and have 72 hours to finish the physical recall. DRAP is proposing to change those figures to 48 hours and seven days. Similarly, the agency plans to extend the deadline for completing Class II recalls from 10 to 23 days.

Other planned changes include the addition of Class IV recalls. DRAP plans to use the new class for minor defects in packaging or other printed materials. When such a defect is found, DRAP will send a “caution in use notice” to communicate that there is a defect, but there is no threat to patients. The agency may also send notices when a defective product cannot be recalled because of supply concerns.

DRAP is proposing fewer revisions to the guidance on establishing pharmaceutical units and post-license changes, the first edition of which came into effect last year. The agency wants to add a new subsection on applying for a no-objection certificate for importing machinery and equipment at a reduced customs duty. The proposed section outlines the materials that applicants should provide.

The agency is also considering changes to existing sections. DRAP is seeking feedback on plans to ban companies from establishing pharmaceutical units on rented premises, cap how lengthy approvals for the layout of buildings last and establish a procedure for re-inspection of rejected site proposals.

DRAP posted the recall and GCP inspection drafts on 21 and 22 February, respectively, and is accepting feedback for 15 days. The pharmaceutical unit draft is open for comment until 7 March.

GCP Inspections, Recalls, Pharmaceutical Units

MDA seeks feedback on guidance for bringing HIV self-testing kits to Malaysian market

Malaysia’s Medical Device Authority (MDA) is holding a consultation about planned guidance on placing HIV self-test kits on the market. MDA published the guidance in August and seeks feedback on a nearly identical text (RELATED: Asia-Pacific Roundup, Regulatory Focus, 23 August 2023).

Last year, MDA published guidance that covered pre-market actions, placing tests on the market, and post-market requirements for HIV self-testing kits. The text described the World Health Organization’s introduction of HIV self-testing to reach people often missed by traditional testing and set out the process for registering kits in Malaysia. MDA created an abbreviated pathway for some tests.

Now, the agency is holding a consultation on the guidance. The text released for consultation is almost identical to the guidance MDA published last year. The main change relates to the accreditation that sites need to evaluate HIV self-tests. The original text stated, “any accredited local institute/laboratory with ISO 17025” can evaluate the tests. DRAP’s draft says sites need “ISO 15189, Medical laboratories - Requirements for quality and competence.”

MDA is accepting feedback until 1 March.

MDA Notice, Draft Guidance

Medsafe outlines pathway for OTC pseudoephedrine

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has described the process for companies that want to sell products containing pseudoephedrine in the next cold and flu season.

Patients currently need a prescription to get pseudoephedrine-based cold and flu medicines. That is set to change on 21 March, when legislation reclassifying pseudoephedrine from a prescription medicine to a restricted one will come into force.

Ahead of the change, Medsafe has asked companies that want to sell pseudoephedrine medicines in the upcoming cold and flu season, which runs from May to October, to send information by 28 February. The pre-submissions will enable Medsafe to assess eligibility for its priority provisional evaluation pathway.

“Medsafe needs to plan this evaluation work taking into account other work underway. Depending on the volume of applications for pseudoephedrine products, it’s likely that we will have to restrict the number of applications accepted for evaluation under priority in this first stage,” the agency wrote.

Products approved in Australia, Canada, the UK, or the US are most likely to be eligible for the pathway, Medsafe said. The agency is asking companies to submit new medicine applications (NMAs) after it has accepted their products for priority evaluation. Applicants must provide evidence of overseas approval and other materials in their NMAs.

Medsafe Notice, Pseudoephedrine Legislation

Australia’s TGA joins with international peers to coordinate GMP inspections globally

Australia’s Therapeutic Goods Administration (TGA) has begun piloting a good manufacturing practice (GMP) single inspection program (SIP) with its international peers.

TGA has joined with all members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), International Coalition of Medicines Regulatory Authorities (ICMRA) and Access Consortium for the project.

“This pilot aims to establish a coordinated global approach to GMP inspections of foreign manufacturing sites of common interest. Using our collective inspection resources, each authority has agreed to extend the scope of an inspection to cover products of interest to one another, where possible, reducing the need for multiple inspections of the same site,” TGA said.

The project builds on existing collaborative GMP arrangements to “allow for more efficient inspection reliance processes, reduced regulatory burden on industry and enhanced collaboration in our regulatory oversight of common global supply chains,” according to TGA.

TGA and its collaborators are now in the “preliminary stages of identifying sites.”

TGA Notice

Asia-Pacific Roundup: Pakistan floats guideline changes on GCP inspections and more

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