Regulatory Focus™ > News Articles > EMA Announces Adoption of Q11 Guidance

EMA Announces Adoption of Q11 Guidance

Posted 25 May 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) is moving quickly to implement the International Conference on Harmonization's (ICH) Quality (Q) 11 guidance, saying it has adopted the standard and plans to implement it by the end of 2012.

The guidance pertains to the drug development process and describes information necessary for inclusion in the Common Technical Document (CTD). The guidance also clarifies existing guidance, including its Q8, Q9 and Q10 guidance documents.

ICH released the Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological Biological Entities guidance on 11 May 2012, and said it was simultaneously moving to notify ICH signatory countries so they could implement the guidance. ICH members include the US, EU and Japan.

EMA said its Committee for Medicinal Products for Human Use (CHMP) had adopted the Q11 proposal in May 2012, and the guidance will come into effect in the EU in November 2012.


Read more:

ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities)

Regulatory Focus - ICH Finishes Q11 Quality Manufacturing Guideline, Prepares to Notify Regulators


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