Regulation and Prequalification
Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.

The International Conference of Drug Regulatory Authorities (ICDRAs) provide drug regulatory authorities of WHO Member States with a forum to meet and discuss ways to strengthen collaboration. The ICDRAs have been instrumental in guiding regulatory authorities, WHO and interested stakeholders and in determining priorities for action in national and international regulation of medicines, vaccines, biomedicines and herbals.

The conferences have been held since 1980 with the aim of promoting exchange of information and collaborative approaches to issues of common concern. As a platform established to develop international consensus, the ICDRA continues to be an important tool for WHO and drug regulatory authorities in their efforts to harmonize regulation and improve the safety, efficacy and quality of medicines.

Regulatory authorities are continually faced with new issues - such as globalization and extension of free trade - while increased responsibilities from expansion of the market and the improvement and sophistication of products place heavy demands on regulatory systems and knowledge bases. The development of cutting edge technologies and health care techniques and extensive use of the Internet impose further complex challenges.

The ICDRA programme is developed by a planning committee of representative drug regulators. Topics discussed during the four days of the ICDRA, may include quality issues, herbal medicines, homeopathy, regulatory reform, medicines safety, counterfeiting, access, regulation of clinical trials, harmonization, new technologies and e-commerce. Recommendations are proposed for action among agencies, WHO and related institutions.

 


Extraordinary (virtual) International Conference of Drug Regulatory Authorities (ICDRA)

20 to 24 September 2021

The World Health Organization held an extraordinary International Conference of Drug Regulatory Authorities (ICDRA) on September 2021. This virtual conference gave the opportunity to the global regulatory community and other key stakeholders to exchange information, best practices and collaborative approaches related to regulation of medical products, especially important during the current challenging times of the COVID-19 pandemic. The decision for the extraordinary ICDRA was taken as the planned 2020 ICDRA which should have taken place in India had to be cancelled due to COVID-19 pandemic. The conference is intended to bridge to the 19th ICDRA, which will be organised in India in 2022, when situation permits.

The theme of the Extraordinary (Virtual) Conference was “Smart Regulation: Timely Delivery of Quality Assured Medical Products for All during the Global Pandemic”. The Conference was held virtually with daily sessions of two hours from 13:00 to 15:00 (CET) from Monday 20 to Friday 24 September 2021.

 


Upcoming ICDRA Meetings

Central Drugs Standard Control Organization (CDSCO) of India will host the 19th International Conference of Drug Regulatory Authorities (ICDRA).

The International Conference of Drug Regulatory Authorities (ICDRAs) has been an indispensable platform for WHO Member States' medical product regulatory authorities, fostering collaboration and setting priorities in medicine regulation since 1980. These conferences have served as a cornerstone in enhancing the safety, efficacy, and quality of medical products worldwide.

WHO and CDSCO India, as the hosts of the 19th ICDRA Conference, are pleased to announce that the event will take place from October 14-18, 2024, in New Delhi, India. Hosted by the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, Government of India, in collaboration with the WHO, this conference promises to be a significant milestone in our ongoing efforts towards "Smart Regulation: Delivering Quality Assured Medical Products for All."

The first two days of the Conference (pre-ICDRA: October 14-15, 2024) will be open to all interested stakeholders. The last three days (main ICDRA: October 16-18, 2024) will be exclusive to representatives of national and regional regulatory authorities for medical products. This event promises insightful discussions, exchange of information, and collaborative strategies to address common challenges in the regulation of medical products. Registration for the 19th ICDRA Conference is now open via the official website.

Past meetings

18th International Conference of Drug Regulatory Authorities (ICDRA)

Dublin - Ireland
ICDRA: 3 - 7 September 2018

18th ICDRA Official Website

18th ICDRA recommendations

17th International Conference of Drug Regulatory Authorities (ICDRA)

Cape Town - South Africa
Pre-ICDRA: 27 - 28 November 2016
ICDRA: 29 November - 02 December 2016

16th International Conference of Drug Regulatory Authorities (ICDRA)

Rio de Janeiro - Brazil - 24-29 August 2014

15th International Conference of Drug Regulatory Authorities (ICDRA)

Tallinn - Estonia, 23-26 October 2012


14th International Conference of Drug Regulatory Authorities

Singapore, 30 November - 3 December 2010

13th International Conference of Drug Regulatory Authorities

Bern, Switzerland, from 16-19 September 2008

12th International Conference of Drug Regulatory Authorities

Seoul, Republic of Korea, April 3 - 6, 2006

11th International Conference of Drug Regulatory Authorities

Madrid, Spain, 16–19 February 2004

10th International Conference of Drug Regulatory Authorities

Hong Kong, China, 24–27 June 2002

9th International Conference of Drug Regulatory Authorities

Berlin, Germany, 25–29 April 1999

8th International Conference of Drug Regulatory Authorities

Bahrain, 10–13 November 1996