| August 02, 2022 | By
Australia’s Therapeutic Goods Administration (TGA) has adopted four strategic goals as part of its business plan for its 2022-23 financial year. The document sets out TGA’s product regulations, stakeholder engagement, and compliance and innovation program for the coming year.
A year ago, TGA listed product regulation and safety, regulatory reform, international engagement, education and compliance as its priorities for 2021 and 2022. These themes recur in the latest business plan , but TGA is changing its focus, guided by the principles of improvement, risk-based and data-driven efforts, and collaboration and engagement. The principles led TGA to develop four goals, along with related performance indicators, and execute them through industry representatives.
TGA has captured several activities under each strategic objective. The objective of improving public health outcomes covers priority assessments of COVID-19 related products, medicinal cannabis reforms, implementation of the medical devices action plan, etc.
To assess its performance against the strategic public health objective, the TGA will examine its ability to meet product approval and regulatory review targets, provide rapid access to innovative therapies and propose “regulatory reforms”. when evidence of real value and benefits is determined, or when risks can be managed appropriately.
The agency has provided performance indicators and areas of focus for the coming year for each of the other strategic objectives. TGA’s other three strategic objectives are: to actively engage with stakeholders, to promote compliance with regulatory requirements, to innovate and to continuously improve. The compliance objective includes implementing TGA’s good clinical practice and pharmacovigilance inspection programs and improving its data analysis capabilities.
The TGA wants to further integrate “operational intelligence to improve the efficiency and focus of our education, compliance and enforcement activities, for example, in compliance reviews of listed medicines.” The agency’s compliance performance indicators include using data and intelligence to identify compliance risks and addressing serious, deliberate and repeated non-compliances.
New Zealand’s Medsafe finalizes opioid abuse warning
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has finalized its warning and advice on opioids. Opioids, with few exceptions, will be labeled “there is a risk of overdose and dependence when using this drug”.
Following a recommendation from the Adverse Drug Reaction Committee to minimize opioid misuse, abuse and dependence, Medsafe held a consultation on plans to establish a new warning earlier this year. The consultation received 41 responses. Medsafe said “most respondents supported the new warnings and cautions.”
However, some sponsors pushed back against the proposal in their responses to Medsafe. An anonymous New Zealand-based sponsor said: “a warning and precautionary statement printed on commercial primary packaging for opioids will not be effective as the information may not reach many patients”. The sponsor stated that opioids are rarely distributed in commercial primary packaging. Instead, the pharmacist removes them and dispenses them in secondary packaging.
Other sponsors accepted the need for a warning but chose different wording than that ultimately chosen by Medsafe, such as “[name of opioid] is an addictive substance. Health organizations and some sponsors favored the same warning as Medsafe.
The agency was also pushed back on the transition period for the new statement. Initially, Medsafe offered a transition period of 12 months. Several sponsors have called for a longer transition period, with one saying that “significant” manufacturing 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 the September 1 label declaration database update, giving industry until March 2024 to comply.
The new statement will replace the statement currently required 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 obstetrical analgesia, or for opioid dependence.
Pakistan’s DRAP taps Australia’s former GMP chief to help bolster inspection system
The Medicines Regulatory Authority of Pakistan (DRAP) has called on Bob Tribe, former Chief Inspector of Good Manufacturing Practices (GMP) of the TGA, to help them strengthen their inspection system and do progress towards the Convention on Pharmaceutical Inspection and the Program of Cooperation in Pharmaceutical Inspection (PIC/S) membership.
The DRAP is the latest regulator to turn to Tribe for help. During a recent visit to Pakistan, Tribe conducted a GMP audit, held a training session and met with regulators, inspectors, industry and DRAP senior management to discuss the current level of the GMP inspection system. Tribe advises on assessing gaps in the inspection system to harmonize with PIC/S GMP standards.
Japanese PMDA Releases English Translation of Risk Management Plan Q&As
The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has released an English version of a recent question and answer document on risk management plans.
PMDA has revised the questions and answers in conjunction with the publication of a document on risk management plan templates, instructions and publication earlier this year. The document template, which was also recently translated by PMDA, covers the preparation of risk management plans, submission of draft plans as part of marketing authorization applications, modification of plans, etc. .
Q&A has 49 questions and answers, several of which refer to the document template. The PMDA used the questions and answers to clarify the timing of the release of plans that are submitted before the approval date, whether it is possible to submit plans before the drug succession date, and what documents need to be filed when modification of plans.
Malaysian NPRA Updates Guidance Notes Regarding API Information for Product Registration
The Malaysian National Drug Regulatory Agency (NPRA) has updated its guidance notes for Active Pharmaceutical Ingredient (API) information for product registration. The updated document presents an expanded list of atypical APIs.
ANRP has created guidance notes to help companies complete product registration applications through its QUEST system. The guidance covers the process for applying for registration of new products, how to submit drug master files, how to reference prequalification by the World Health Organization, and the regulatory control of atypical APIs.
The update concerns an annex that lists atypical APIs, defined as excipients, food additives or cosmetic ingredients used as active ingredients in pharmaceutical products. Atypical APIs, which pose lower risks and are widely used outside the pharmaceutical industry, are subject to different regulatory requirements.
The NPRA added seven atypical APIs including taurine, omega-3 rich fish oil and magnesium acetate to the schedule, expanding the list to cover 61 ingredients. The list is not intended to be exhaustive and will be the subject of subsequent examinations by the ONPR.
India’s Department of Pharmaceuticals seeks information from domestic manufacturers who supply or wish to supply raw materials used in the production of vaccines and biologicals. The request is aimed at producers of products including bags for micro-reactors and cell culture media. DoP Notice
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