In early 2017, the United States Pharmacopeial Convention (USP), European Medicines Agency and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) finalised guidelines (ICH Q3D and USP ) containing new permitted daily exposure …
In October 2013, the Therapeutic Goods Administration (TGA) announced the launch of the Medical Device Single Audit Program (MDSAP) pilot from January 2014, together with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the US Food and …
The National Commission of Audit Recommendation 19 could significantly improve the cost and time to market for new drugs. The Commission cites the example of Atorvastatin, currently the most highly prescribed and highest cost to government medicine in Australia, New Zealand only pays $2.01 …
The TGA has announced that it has signed an agreement to use the docuBridge® software solution to receive, review and process electronic applications for the entry of prescription medicines and other therapeutic products on to the Australian Register of Therapeutic Goods (ARTG).
EU guidelines
A number of EU guidelines have been proposed for adoption or non-adoption by the TGA. These are now open for comment until 19 August 2013. The guidelines in question are listed below:
Guideline on quality aspects on the isolation …
The ICH Steering Committee and its Expert Working Groups met in Belgium in June 2013. The Steering Committee agreed measures aimed at increased transparency in pursuit of greater harmonisation and will provide more detail to the public via the …
The impact of recent changes to the “Internationally harmonised requirements for Batch Certification”?
The European Union (EU) has reformed the rules for importing active pharmaceutical ingredients into the EU for medicinal products for human use.
As of 2 January 2013, all …
It is not unusual for Pharmaceutical Quality Systems (PQS) to be perceived, as ‘expensive’ and ‘non-value adding,’ by some areas of a GMP organisation. Often managers with Lean or Six Sigma backgrounds struggle to make the correlation between GMP …
This concept paper addresses the need to update Annex 17 (Parametric release) of the EU GMP Guide. At the time the original guideline was adopted (January 2002), the main foreseen application area was sterility testing, with a particular focus …
Regulators from several APEC countries met in Taiwan in early November for the second workshop on Good Review Practices. This was an advanced workshop, following on from the initial meeting held in Taipei in October 2011. The workshop was …
