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News about GMP/cGMP

2013-06-17

Japan has been added to the "list of third countries" as regards standards of manufacture and supervision of active pharmaceutical ingredients equivalent to those of the EU.

 
2013-06-12

Following consultation with relevant industry groups, TGA, the Australian Therapeutic Goods Administration, has announced the adoption of a number of EU/ICH guidelines in Australia, effective 1 June 2013.

These include, inter alia:

  • Guideline on plasma-derived medicinal products (EMA)
  • Guideline on active substance master file procedure (EMA)
  • Guideline on bioanalytical method validation (EMA)
  • Impurities: Guideline for residual solvents ICHQ3C(R5)
Source:

TGA: Newsroom

 
2013-06-05

China’s State Food and Drug Administration (SFDA) is now under new leadership and has changed its name to "The China Food and Drug Administration – CFDA".

 
2013-06-05

The Chinese Authorities have recently released a few newslets, one concerning the “Written Confirmation for active substances exported to the EU”, an omnipresent topic.

 
2013-06-05

On 24 May 2013, the FDA has published a draft guidance for industry entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements”. The guidance describes the current thinking of the government authority on defining, establishing and documenting the responsibilities of all parties involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP).

 
2013-05-29

As announced by Health Canada last week, Harper Government plans on strengthening drug safety with new standards, as Good Manufacturing Practices now apply to all active pharmaceutical ingredients

 
2013-05-28

The WHO has published a proposal for revision of the Supplementary Guidelines on GMP: Validation, Appendix 7: Non-sterile Process Validation in April 2013. The revised document is expected for October 2013, after its presentation to the WHO Expert Committee on Specifications for Pharmaceutical Preparations.

 
2013-05-15

The European Medicines Agency (EMA) has announced the first details of its planned reorganisation. Rooted firmly in the Agency’s overall public and animal health mission, the changes reflect a renewed focus on three key elements:

  • how to better support the scientific work of the EMA committees,
  • how to better share the data the Agency holds and
  • how to better meet the needs of its stakeholders and partners.
 
 
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