Asia-Pacific Roundup: New Zealand updates pharmacovigilance guideline
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has updated its guideline on pharmacovigilance after receiving support for changes it proposed late last year.Medsafe ran a consultation in November and December to gather feedback on plans to change its advice on collecting and reporting suspected adverse reactions and what it treats as a significant safety issue. The plans included the introduction of the “other safety issue” category. Medsafe wanted to know if it had clearly explained the safety categories and the sponsor’s role in collecting adverse reaction reports.
The agency received 15 submissions to the consultation, all of which were sent by sponsors or other organizations involved in pharmacovigilance activities.
“Most respondents agreed with the proposed updates,” according to Medsafe. “Several respondents suggested changes to wording, layout and/or formatting to improve clarity. There were also requests to add examples or further detail to some sections to improve understanding and interpretation. Where appropriate, we have incorporated these suggestions into the revised guideline.”
Medsafe added that the responses provided by some respondents indicated that they may have read a subsection of the guideline in isolation. “This may have led respondents to misinterpret parts of the guideline,” the agency said. Medsafe stressed that sponsors need to read each section of the document in its entirety.
Two respondents asked for a timeframe for giving Medsafe the details of their pharmacovigilance contact person, leading the agency to ask sponsors to submit the information within 15 days of winning approval for a product. Sponsors also have 15 days to tell Medsafe about changes to the contact person’s details.
Feedback on the introduction of the “other safety issue” category was positive overall, according to Medsafe, and the agency retained the concept in the revised guideline. Two respondents called for New Zealand’s categories to be more closely aligned with the groupings used in Australia. In response, Medsafe said it believes the criteria are “very similar” and added information about the different types of safety issues.
The agency reviewed and updated its section on significant safety issues after some respondents said the text was “too vague” and may result in events going unreported. Seven respondents said the draft failed to clearly explain the difference between the two types of safety issues.
“Sponsors should use their professional judgment to determine whether a safety issue is significant,” the agency said. “This includes assessing the impact on the medicine’s safety, benefit-risk balance and/or implications for public health. If sponsors are unsure whether a safety issue is a significant safety issue or not, we recommend notification.”
Some respondents asked about the different requirements for reporting adverse reactions in the draft pharmacovigilance text and another guideline on the requirements for clinical trials. Medsafe said the differences reflect the “different situations,” although it also added that it is revising the clinical trial guideline and will provide updated information about reporting adverse reactions.
Medsafe Notice
Philippine FDA seeks feedback on planned changes to GMP filings, drug registrations
The Philippine Food and Drug Administration (FDA) has released draft guidelines for consultation on good manufacturing practices (GMPs) and the registration of pharmaceutical products.
FDA has proposed adopting the GMP draft and repealing existing guidelines on GMP clearance and inspection of foreign drug manufacturers to bring “inclusivity and coherence” to its regulatory system, address emerging concerns, and “be abreast with internationally acceptable standards.”
The draft features revised processes and procedures for initial and re-issuance GMP applications. FDA has prioritized integration with information and communication technologies “to maximize a focus on risks, promote coordination and information-sharing, and ensure an optimal use of resources.” The agency also wants to make the rules clearer and act on “the recent [World Health Organization] audit.”
FDA is accepting feedback on the GMP draft until 16 April. The comment window for the registration drafts closes on 26 April. In the registration document, FDA sets out the process for pharmaceutical products and drug substances that are made but not used in the Philippines. Manufacturers of such products and substances need to apply for export-only authorization.
The draft outlines the process for receiving export-only authorization, including the documents that applicants need to provide and the eligibility criteria they need to meet. Manufacturers of export-only products must evaluate their impact on drug supply in the Philippines, and the FDA can suspend authorizations if exports will cause or aggravate a shortage in the country.
Holders of export-only authorizations must immediately tell FDA about “any incident that reasonably indicates that the product exported has caused or contributed to the death, serious illness or serious injury.” FDA also expects to receive reports when a product “is found substandard or declared banned in the importing country.”
Draft Guidelines, More
Malaysia’s NPRA updates guideline on clinical trial import licenses and exemptions
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated its guideline on applying for clinical trial import licenses and exemptions.
The eighth version of the document, which replaces a text adopted in 2021, features a new section on reporting suspected unexpected serious adverse reactions. NPRA expects sponsors to report safety information generated in studies authorized under clinical trial import licenses and exemptions. The reporting of safety findings from other studies, such as Phase 4 trials, is outside of the scope of the text.
Reporting must start on the date NPRA authorizes a license or exemption and continue until the sponsor has either submitted the end-of-study reports for all Malaysian sites or the authorization has expired. The agency is asking sponsors to send reports as PDFs via email.
NPRA has also added a new subsection on the process for vaccines and added details of investigational products that contain dangerous drugs to an existing subsection. The agency has provided an appendix that shows how to provide vaccine-quality documents and asked applicants to read its guidelines alongside documents from US, European and international bodies.
Updated Guideline
Indian Pharmacopoeia Commission inks memorandum of understanding with USP
The Indian Pharmacopoeia Commission (IPC) has formed a memorandum of understanding (MoU) with its US counterpart.
Rajeev Singh Raghuvanshi, secretary-cum-scientific director at IPC, called the agreement a key moment in the ongoing collaboration between them two groups. The agreement follows IPC’s acceptance into the Pharmacopeial Discussion Group, an international project that brings representatives of the US, EU and Japan together to drive the harmonization of standards.
USP said the MoU indicates an “ongoing commitment to collaborate to support the production of quality pharmaceuticals.” Raghuvanshi signed the agreement on a visit to USP's hub in Rockville, MD, at which he shared insights and perspectives about pharmaceutical opportunities and challenges in India.
IPC Statement
Other news
The Drug Regulatory Authority of Pakistan (DRAP) has published the second edition of its guidelines on good clinical practice inspections. DRAP updated the text to make it easier to understand the inspection procedure and explicitly extend the scope of the guidelines to contract research organizations and other groups involved in clinical trials. DRAP Notice
