Pharmacovigilance guidelines

10 April 2015

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Please note: Where European Union (EU) guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of prescription medicines by the TGA. The Australian legislative requirements applying to prescription medicines are contained in the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990, as well as in various legislative instruments such as Therapeutic Goods Orders, Notices and Determinations, see Legislation.

See also Australian pharmacovigilance requirements and recommendations for medicine sponsors

Note: Australian requirements take precedence in situations where details of processes and requirements differ between the Australian and European/ICH guidelines. Reference to European regulatory bodies and processes do not apply in Australia.

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EMA/838713/2011 Rev 1* (pdf,772kb)*
Guideline on good pharmacovigilance practices (GVP) Module V - Risk management systems (Rev 1)
Replaces: EMA/838713/2011 Guideline on good pharmacovigilance practices (GVP) Module V - Risk management systems. (Adopted by TGA 10 April 2014)
Effective: 10 November 2014

TGA annotations:
V.B.8.8 RMP module SVII "Identified and potential risks (ATMP version)": The TGA will accept all EU RMP modules relating to advance therapy medicinal products (ATMPs) for products not classed as biologicals in Australia.
V.B.11.2 RMP part V section "Additional risk minimisation activities": The TGA does not necessarily require educational materials for same substances to be similar in layout, colour and format. The key safety messages should be in all products which are the same.
V.C 3.1 Requirements in specific situations: This section is not applicable to TGA Please refer to Risk management plan (RMP) questions & answers
V.C.5 Updates to the risk management plan: In line with changes in the EU, updated EU RMPs should be submitted at the request of the TGA and whenever the EU RMP is modified as a result of new information which may change the risk-benefit of the product or as a result of an important pharmacovigilance or risk minimisation milestone being reached.

EMA/816292/2011 Rev 1 (1.45Mb)*
Guideline on good pharmacovigilance practices (GVP).
Module VII - Periodic safety update report (Rev 1).

Replaces: pp. 21-32 and 139-145 of Rules 2001 (Vol. 9). Periodic Safety Update Reports (PSURs) Sections 1.4 and 3 of Part 1 (Adopted by TGA 2 October 2002)
Effective: 21 July 2014

TGA annotations:
The TGA is adopting the Guideline on good pharmacovigilance practices (GVP) module VII Periodic Safety Update Reports (Rev 1) Sections VII. A, VII. B and VII.C. 4.3. - 6.1., including the EU-specific requirements and all appendices including those in VII.C.5. and after VII.C.9.3. Reference to specific European legislation, regulatory bodies and processes do not apply in Australia. The frequency of PSUR submission may not align with that in the EU and the usual requirement in Australia is that PSURs are to be submitted annually for 3 years post registration or after changes to registration, as specified in the approval letter. Section VII.C.7 does not, at this time, apply as the TGA is not proposing to publish PSUR reports or to routinely provide these to sponsors.

Note For Guidance On Clinical Safety Data Management: Definitions And Standards For Expedited Reporting - Annotated with TGA comments
Effective: 1 August 2000

EMA/CHMP/ICH/544553/1998 (pdf,476kb)
ICH guideline E2C (R2) on periodic benefit-risk evaluation report (PBRER)
Replaces: CPMP/ICH/4679/02. Clinical Safety Data Management - Periodic Safety Update Reports for Marketed Drugs (Addendum to ICH E2C - CPMP/ICH/288/95) (Adopted by TGA 7 June 2005)
Effective: 21 July 2014

CPMP/ICH/5716/03 (pdf,225kb)
ICH Topic E 2 E
Note for Guidance on Planning Pharmacovigilance Activities

Effective: 10 August 2005

EMEA/CHMP/PhVWP/235910/2005- rev.1 (pdf,82kb)
Guideline on Conduct of Pharmacovigilance for Medicines Used by the Pediatric Population
Replaces: EMEA/CHMP/PhVWP/235910/2005 (adopted by TGA 16 March 2009)
Effective: 21 July 2014

EMEA/CHMP/313666/2005 (pdf,277kb)
Guideline on the Exposure to Medicinal Products during Pregnancy: Need for Post Authorisation Data
Effective: 26 February 2009

EMA/488220/2012 (pdf,286kb)
Guideline on good pharmacovigilance practices (GVP)
Product- or Population-Specific Considerations I: Vaccines for prophylaxis against infectious diseases

Replaces: EMEA/CHMP/PhVWP/503449/2007 Guideline on the Conduct of Pharmacovigilance for Vaccines for Pre- and Post-Exposure Prophylaxis Against Infectious Diseases
(Adopted 17 December 2010)
Effective: 4 September 2014

TGA annotation:
P.I.C.2.1.Reporting of vaccination failures: Lack of efficacy of a vaccine, as signified by the occurrence of breakthrough infection, is considered to fall within the definition of a serious adverse drug reaction (ADR) and is therefore subject to the expedited reporting requirement as stated in the Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines.

EMEA/359381/2009 (pdf,144kb)
CHMP Recommendations for the Pharmacovigilance Plan as Part of the Risk Management Plan to be Submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine
Effective: 26 March 2010