Asia-Pacific Roundup: TGA seeks feedback to improve MDSAP

Australia’s Therapeutic Goods Administration (TGA) is running an industry survey to “better understand any concerns with the operation” of the Medical Device Single Audit Program (MDSAP).

A group of international regulators including TGA and the US Food and Drug Administration (FDA) set up MDSAP in 2016 so that a single regulatory audit could satisfy the needs of multiple regulatory jurisdictions. Under the program, medical device companies undergo a single regulatory audit by a third party to get a report that is accepted in multiple countries including Australia, Brazil, Canada, Japan and the US.

TGA wants feedback on the process. “By completing this survey, your response will help us to better understand any concerns with the operation of the program. Sponsors may reach out to applicable manufacturers for help answering specific questions on audit activities, if necessary, although the intent of the survey is to better understand the sponsor interactions during MDSAP audits,” TGA wrote.

The TGA survey starts by providing background information on the responsibilities of Australian sponsors, written agreements between Australian sponsors and manufacturers, and manufacturer responsibilities.

TGA is asking sponsors that are using MDSAP to support Australian Register of Therapeutic Goods (ARTG) entries whether they have “been asked to provide information for an MDSAP audit before, during or after an audit of the manufacturer.” Sponsors that answer yes are asked whether they believe the MDSAP auditor’s request for information was within the scope of the audit and, if they answer no, whether the auditor asked for details that were not readily available.

Other questions ask whether the sponsor aids a manufacturer to meet requirements of the essential principles or other ISO13485:2016 requirements, whether they have undergone a direct audit, and, if so, what their experience was like. TGA wants to know if the auditing body communicated clearly “leading up to, during and following the audit, including issuing of a certificate” and whether any nonconformities were raised related to the information provided by the sponsor.

Another set of questions covers communications with TGA about MDSAP. The administration wants to know if sponsors have received “timely and accurate information” related to MDSAP and how long they had to wait. The survey also gives sponsors a chance to share additional comments about MDSAP, its implementation and the role TGA plays in the program.

The survey, which opened on 25 August, closes on 1 September.

TGA Notice

Pakistan’s DRAP raises ‘great concern’ about industry pharmacovigilance practices

The Drug Regulatory Authority of Pakistan (DRAP) has voiced “great concern” about the failure of most pharmaceutical companies to nominate a qualified person for pharmacovigilance (QPPV) or local safety officer (LSO).

DRAP published guidelines on good pharmacovigilance practices for registration holders last year. The guidelines outlined the need for registration holders to have a QPPV or LSO, depending on whether they are a local or multinational company, and listed the information they need to provide to DRAP. In July, DRAP wrote to registration holders to ask them to submit the requested pharmacovigilance information.

The request failed to have the desired effect. In a second notice, DRAP expressed “great concern that a few pharmaceutical companies have submitted their nomination of QPPV/LSO to the National Pharmacovigilance Centre (NPC) in spite of the [earlier] communication.” DRAP has given registration holders 30 days to submit the information and materials requested.

DRAP framed the use of a QPPV or LSO to “ensure the highest standards of quality and safety.” The authority added that “pharmacovigilance is not only a legal obligation but also a social responsibility” that can “enhance reputation, credibility and competitiveness of a product in the global market.”

DRAP Notice

Japan’s PMDA provides update on managing nitrosamine contamination risks

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published an update on the safety measures that it and drug manufacturers are adopting to mitigate the risks of nitrosamine contamination.

In the August edition of its Pharmaceuticals and Medical Devices Safety Information report, PMDA discusses the background to the problem, from the detection of N-nitrosodimethylamine in a drug substance manufactured by Zhejiang Huahai Pharmaceutical in 2018 through to the 2021 order for marketing authorization holders to assess the risk of contamination.

The deadline for evaluating the risk of contamination passed the end of April. PMDA requires products that are at risk of contamination to be evaluated for nitrosamines “using an appropriate number of lots.”

Manufacturers of products that contain nitrosamines above the acceptable limit must promptly report the problem to Japan’s Minister of Health, Labour and Welfare. PMDA is giving manufacturers until 31 October 2024 to implement “risk mitigation measures such as setting specifications and changing the manufacturing method to reduce the amount of nitrosamines.”

Companies that need to file an application for approval of a partial change or a notification of a minor change must submit their paperwork by 31 October 2024. The PMDA report also discussed the process used to assess the risk of nitrosamines and the discovery of N-nitrosonortriptyline in nortriptyline products. Patients should continue taking the products until they consult with their physicians to avoid withdrawal symptoms related to rapid dose reduction or discontinuation of treatment.

PMDA Notice

MDA shares guidance on bringing HIV self-test kits to market in Malaysia

The Medical Device Authority (MDA) has shared new guidance on placing self-test kits for HIV on the Malaysian market.

In the first edition of the guidance, which was published late last week, MDA discusses the World Health Organization’s introduction of HIV self-testing to reach people who are often missed by traditional testing. MDA said self-testing “could be used as an effective method for controlling HIV risk transmission” and may later support a pre-exposure prophylaxis program for high-risk people.

The guidance presents the registration process for HIV self-tests depending on whether the product has pre-market approval in recognized countries or not. Developers of products that are yet to win approval overseas must have the sensitivity and specificity of their test assessed by an accredited local laboratory and undergo a full conformity assessment.

Products with pre-market approval from recognized countries can skip the assessment by an accredited local laboratory and only need to undergo a conformity assessment that verifies the existing certificate. The requirements for the two sets of self-test kits are otherwise the same.

The guidance also covers topics such as labeling, instructions for use, the need for video tutorials and how to dispose of the kits. HIV self-test kits are already available in countries, such as Australia, that are recognized by MDA.

MDA Guidance

Other news:

TGA has updated its information for sponsors and manufacturers on nitrosamine impurities in medicines. The agency originally published the information in January. TGA Notice

Asia-Pacific Roundup: TGA seeks feedback to improve MDSAP

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