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Tech alert: Reminder - Consultations closing: Pharmacovigilance; EU Guidelines

15 Feb 2022 10:12 AM | Anonymous member (Administrator)

Reminder: Pharmacovigilance Survey for Sponsors closing this Friday 18 Feb 2022.

The TGA is seeking feedback to help inform them how to best tailor what data sponsors would like to view or extract as part of the TGA's Medicines Adverse Data Exchange project, which seeks to improve the management of medicines safety signals by improving how the TGA share medicine adverse events data and making it easier for health professionals to report adverse events.

CMA have asked TGA for better and easier access to data for listed medicines to make PV obligations easier. This is your opportunity to have your say directly on outcomes.

The consultation proposes to implement new functionality that allows sponsors to view and export documents with de-identified medicine adverse event data from TGA systems using existing sponsor authentication. Feedback is sought, e.g.:

- What medicine adverse event data sponsors wish to view and/or extract from TGA’s Adverse Events Management System.

- The preferred format(s) for the extracted data to support its upload into sponsor systems.

Start the survey here and view the consultation page here. Some of the survey questions require some thought and team discussion - information and survey questions can be accessed prior to starting the survey at this consultation document.

Reminder: European Guidelines Survey closing this Sunday 20 Feb 2022.

The TGA is seeking feedback on whether or not certain international scientific guidelines should be adopted. While they are generally not mandated by legislation (unless included in a standard), the TGA refer to them during pre-market applications for medicines, which can include Registered complementary and Listed Assessed medicine applications. During an application, deviation from a guideline must be justified by the sponsor.

The following proposed guidelines may be of relevance to complementary medicine applications. Respondents to the https://consultations.tga.gov.au/tga/proposed-adoption-of-international-scientific-guid/survey are given the option of supporting, or not supporting and reasons why.

- ICH guideline Q3C (R6) on impurities: guideline for residual solvents (EMA/CHMP/ICH/82260/2006)

- ICH S5 (R3) guideline on reproductive toxicology: Detection of toxicity to reproduction for human pharmaceuticals (EMA/CHMP/ICH/544278/1998)

- Guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease (CPMP/EWP/553/95 Rev. 2)

- Guideline on the clinical development of medicinal products intended for the treatment of pain (EMA/CHMP/970057/2011)

- Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action (EMA/CHMP/CVMP/QWP/336031/2017)

- Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012)       

- Questions and answers on implementation of risk-based prevention of cross contamination in production and Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/246844/2018)

- ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management (EMA/CHMP/ICH/804273/2017)

- Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container

CMA would like to hear from members on how you perceive these pharmacovigilance or EU guidelines proposals will affect the complementary medicines industry and any constructive suggestions. Please contact Lucy.Lang@cmaustralia.org.au

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