There were 1,735 press releases posted in the last 24 hours and 404,773 in the last 365 days.

International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

The ICH Assembly and Management Committee include an EMA representative and the chair of EMA's Committee for Medicinal Products for Human Use (CHMP).

EMA acts as technical coordinator for ICH activities and plays a key role in EU contributions to ICH topics are developed and communicated in a timely manner. European experts nominated by the CHMP participate in the expert working groups that draft the guidelines, and can act as chair or rapporteur responsible for leading the group's work.

EMA supports ICH in its efforts to obtain early stakeholder input on a regional basis towards its good clinical practice (GCP) renovation process, by gathering the views and engaging European stakeholders via its Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties

Once an ICH guideline has been finalised, the CHMP is responsible for implementing it as a European guideline. All harmonised guidelines are published on the EMA website on Scientific guidelines: ICH guidelines.

The Agency also sits on the management board of ICH's Medical Dictionary for Regulatory Activities (MedDRA).

EMA is supporting ICH's pilot regional stakeholder engagement approach for the moderinsation of its good clinical practice guidance (ICH E6(R3)), by facilitating the obtaining of the relevant input in Europe via its Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties. The feedback gathered via EMA in Europe, along with 

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.