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Joint Statement on transparency and data integrity International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO
Joint Statement on transparency and data integrity International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO 7 May 2021 Reading time:
The COVID-19 pandemic has brought into sharp focus the need for information and data to support academics, researchers and industry in developing vaccines and therapeutics; to support regulators and health authorities in their decision-making; to support healthcare professionals in their treatment decisions; and to support public confidence in the vaccines and therapeutics being deployed.
While some initiatives have met with stakeholder support (e.g. WHO International Clinical Trials Registry Platform, US NIH ClinicalTrials.gov database, Health Canada Clinical Information Portal, EMA Clinical Trials Register and Japan Registry of Clinical Trials), not all past efforts have been successful. O
WHO, medicines regulators call on drug manufacturers to open access to clinical data ANI | Updated: May 07, 2021 21:55 IST
Washington [US], May 7 (ANI/Sputnik) : The WHO and the International Coalition of Medicines Regulatory Authorities (ICMRA) urged the pharmaceutical industry to open access to clinical data for all new medicines and vaccines for reasons of overriding public health interest.
Making relevant data on innovative vaccines and medicines readily available will increase public trust in the treatment options, streamline global research efforts, increase data quality and help with healthcare policy making, the document stated. Publication of data allows science to advance faster, by avoiding repetition of unnecessary trials and waste of resources (human and financial). This also brings benefits by improving the efficiency of development programmes and reducing both development costs and time, the official statement said.
Date Time
Statement on transparency and data integrityInternational Coalition of Medicines Regulatory Authorities and WHO
and WHO call on the pharmaceutical industry to provide wide access to clinical data for all new medicines and vaccines (whether full or conditional approval, under emergency use, or rejected). Clinical trial reports should be published without redaction of confidential information for reasons of overriding public health interest.
The COVID-19 pandemic has brought into sharp focus the need for information and data to support academics, researchers and industry in developing vaccines and therapeutics; to support regulators and health authorities in their decision-making; to support healthcare professionals in their treatment decisions; and to support public confidence in the vaccines and therapeutics being deployed.