Roundups| 02 August 2022 | By
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Australia’s Therapeutic Goods Administration (TGA) has adopted four strategic objectives as part of its business plan for its 2022-23 financial year. The document sets TGA’s product regulation, stakeholder engagement and compliance and innovation agenda for the coming year.
One year ago, TGA listed product regulation and safety, regulatory reform, international engagement, and education and compliance as its priorities for 2021 and 2022. Those themes recur in the latest business plan but TGA is tweaking its focus, guided by the principles of continuous improvement, risk based and data driven efforts, and collaboration and engagement. The principles led TGA to develop four objectives, plus related performance indicators, and run them by industry representatives.
TGA has captured multiple activities under each strategic objective. The improved public health outcomes objective covers prioritized evaluations of products related to COVID-19, medicinal cannabis reforms, the implementation of the Action Plan for Medical Devices and more.
To assess its performance against the public health strategic objective, TGA will look at its ability to meet product approval and regulatory assessment targets, provide timely access to innovative therapies and propose “regulatory reforms when evidence of value and real benefit is determined, or when risks can be appropriately managed.”
The agency provided performance indicators and areas of focus for the coming financial year for each of the other strategic objectives. TGA’s three other strategic objectives are: actively engage with stakeholders, promote compliance with regulatory requirements, and innovate and continuously improve. The compliance objective captures the implementation of TGA’s good clinical practice and pharmacovigilance inspection programs and the enhancement of its data analytics capabilities.
TGA wants to further embed “operational intelligence to enhance the effectiveness and targeting of our education, compliance and enforcement activities, for example, in Listed Medicines compliance reviews.” The agency’s compliance performance indicators include the use of data and intelligence to identify the risks of non-compliance and the addressing of serious, deliberate and repeated noncompliance.
TGA Plan
New Zealand’s Medsafe finalizes opioid abuse warning
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has finalized its opioid warning and advisory statement. Opioids, with some exceptions, will carry the statement “use of this medicine has the risk of overdose and dependence.”
Following a recommendation from the Medicines Adverse Reactions Committee to minimize opioid misuse, abuse and dependence, Medsafe held a consultation into plans to establish a new warning statement earlier this year. The consultation received 41 responses. Medsafe said “most respondents were supportive of the new warning and advisory statements.”
However, some sponsors pushed back against the proposal in their responses to Medsafe. An anonymous, New Zealand-based sponsor said, “a warning and advisory statement printed on the commercial primary pack for opioids will not be effective, because the information may not reach many patients.” The sponsor said opioids are rarely dispensed in the commercial primary packaging. Rather, the pharmacist removes them and dispenses them in secondary packaging.
Other sponsors accepted the need for a warning statement but picked a different wording from that ultimately chosen by Medsafe, such as “[name of opioid] is an addictive substance.” Healthcare bodies and some sponsors favored the same warning statement as Medsafe.
The agency also received pushback on the transition period for the new statement. Initially, Medsafe proposed a 12-month transition period. Multiple sponsors called for a longer transition period, with one arguing that “significant” manufacturing lead times mean it “would require at least a 24-month transition period, preferably 36 months.” Medsafe has extended the transition period to 18 months from when it updates the Label Statements Database on 1 September, giving the industry until March 2024 to comply.
The new statement will supersede the currently required statement for prescription codeine products. Medsafe will remove the entry for over-the-counter codeine products from the database. The statement does not apply to opioids indicated solely for anesthetic use or postoperative or obstetric analgesia, or for opioid dependence.
Medsafe Notice
Pakistan’s DRAP enlists Australia’s former GMP chief to help strengthen inspection system
The Drug Regulatory Authority of Pakistan (DRAP) has enlisted Bob Tribe, former TGA chief good manufacturing practice (GMP) inspector, to help strengthen its inspection system and progress it toward Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) membership.
DRAP is the latest regulatory authority to turn to Tribe for help. In a recent visit to Pakistan, Tribe carried out a GMP audit, organized a training session and met with regulators, inspectors, industry and senior management at DRAP to discuss the current level of the GMP inspection system. Tribe is advising on gap assessment of the inspectorate system to be harmonized with PIC/S GMP standards.
DRAP Notice
Japan’s PMDA publishes English-language translation of Q&A on risk management plans
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published an English-language version of a recent question and answer document on risk management plans.
PMDA revised the Q&A in association with the release of a document on risk management plan templates, instructions and publication earlier this year. The template document, which was also recently translated by PMDA, covers the preparation of risk management plans, submission of draft plans as part of marketing authorization applications, making changes to plans and more.
The Q&A features 49 questions and answers, including several that refer to the template document. PMDA has used the Q&A to clarify the timing of the publication of plans that are submitted before the approval date, whether it is possible to submit plans before the date of drug succession and which documents should be filed when making changes to plans.
PMDA Document
Malaysia’s NPRA updates guidance notes for API information for product registration
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated its guidance notes for active pharmaceutical ingredient (API) information for product registration. The updated document features an expanded list of atypical APIs.
NPRA created the guidance notes to help companies complete product registration applications via its QUEST system. The guidance covers the process for new product registration applications, the mode of submission for drug master files, how to reference prequalification by the World Health Organization and regulatory control of atypical APIs.
The update affects an annex that lists atypical APIs, defined as excipients, food additives or cosmetic ingredients that are used as active ingredients in pharmaceutical products. Atypical APIs, which have lower risks and are widely used outside of the pharmaceutical industry, are subject to different regulatory requirements.
NPRA has added seven atypical APIs including taurine, fish oil rich in omega-3 acids and magnesium acetate to the annex, expanding the list to cover 61 ingredients. The list is not meant to be exhaustive and will be subject to further reviews by NPRA.
NPRA Notice
Other news:
The Indian Department of Pharmaceuticals is seeking information from domestic manufacturers that supply, or are interested in supplying, raw materials used in the production of vaccines and biologics. The request is aimed at producers of products including micro-reactor bags and cell culture media. DoP Notice
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