Australia TGA adopts a plethora of EU guidelines

The following EU/ICH guidelines have been adopted by the Australian Therapeutics Goods Administration (TGA), effective 6 January 2017 unless indicated otherwise:

  • EMA/CHMP/594085/2015 – Guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products with effect from 1 February 2017
  • EMA/CHMP/29947/2013/Rev. 4 – Guideline on clinical investigation of medicinal products in the treatment of hypertension
  • EMA/CHMP/50549/2015 – Reflection paper on assessment of cardiovascular safety profile of medicinal products
  • EMA/CHMP/748108/2013, Rev. 3 – Guideline on clinical investigation of medicinal products in the treatment of lipid disorders
  • EMA/CHMP/311805/2014 – Guideline on clinical evaluation of medicinal products used in weight management
  • EMEA/CPMP/EWP/633/02 Rev. 3 – Guideline on the clinical development of medicinal products for the treatment of HIV infection
  • EMA/CHMP/BWP/3354/1999 rev.1 – Guideline on production and quality control of animal immunoglobulins and immunosera for human use
  • EMA/CHMP/BWP/532517/2008 – Guideline on development, production, characterisation and specification for monoclonal antibodies and related products
  • EMA/CHMP/BWP/187338/2014 – Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission
  • EMA/CHMP/BWP/271475/2006 rev.1 – Guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer.

Product-specific bioequivalence guidance has also been adopted. The TGA effective date of the individual guidance is the effective date of the individual guidance. It should be noted that for products which comply with the current non-product-specific bioequivalence guidance (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr) but not the product-specific guidance and an application to TGA is submitted within 2 years of the date of publication of the guidance, sponsors must submit a robust justification for not complying with the non-product-specific bioequivalence guideline.

Regarding the guideline on clinical evaluation of medicinal products used in weight management (EMA/CHMP/311805/2014), we would like to highlight the TGA annotation: “If a sponsor wishes to claim secondary benefits associated with weight loss (such as improved blood lipids, glycaemic control or blood pressure), then the relevant guidelines for these specific benefits should be independently satisfied.”

To read the TGA announcement and access the guidelines on the TGA website, please click here.