The tenth International Conference of Drug Regulatory Authorities (ICDRA) was held this year in Hong Kong. Immediately prior to the conference a satellite workshop was held on “The Impact of Regulation on the Safe Use of Drugs”. There were 57 participants at this event representing 32 Member States.
The objectives of this workshop were to discuss issues relating to the adequate exchange of regulatory information; how to deal with controversial regulatory decisions and how to relate decisions to the interested parties; to identify areas where broader collaboration between Member countries and WHO is necessary; and, to suggest recommendations for the safety session at the main ICDRA.
The workshop was divided into four sessions. The first was devoted to discussions on the current state of information sharing among regulators. Presentations were made from Canada, Ghana and Japan which illustrated some of the differences in pharmacovigilance activities between the better developed drug regulatory authorities and the more recently established ones. There were three themes which appeared to be of common concern. These were the broadening scope of pharmacovigilance including the increasing use of traditional medicines, the need to involve consumers and the need for strengthened collaboration among regulators and international organizations.
The second session concerned the pressures from other regulatory authorities, the media and the pharmaceutical industry. The urgent need for guidelines on crisis management was discussed. A plan needs to be developed for risk management when a drug is marketed in a country. One other topic which emerged from this session was the need for adequate monitoring of antiretrovirals.
The third session dealt with the way in which the pharmacovigilance aspect of regulation interacts with the WHO. A presentation was made by the WHO Programme for International Drug Monitoring on the current status of this programme. Two regulatory authorities, currently contributing to the Programme, spoke of the drawbacks of not having complete data. A number of issues arose during this session. There was a unanimous call for increased transparency in decision-making and the need for earlier information sharing to ensure that decisions are made known to all regulators before they are released to the public. The ICH process was also discussed; there was agreement that WHO should be more actively involved in the standard setting, particularly in the area of the safe use of medicines.
The fourth and final session focused on regulatory issues of traditional medicines and lifestyle drugs. A presentation was made by China on the current status of adverse drug reaction monitoring. It was evident that monitoring the quality of traditional medicines should be an integral part of adverse drug reaction monitoring for traditional medicines. Two presentations were made on special problems with smoking cessation therapies and sildenafil. The political pressure to make these drugs available was discussed.
The recommendations from this workshop were then presented during the session on drug safety monitoring at the tenth ICDRA. The following major recommendations were adopted at the plenary:
1. Regulatory authorities should extend their scope of activities to include: surveillance of medication errors, medical devices, homeopathic products, traditional medicines and natural health products.
2. In order to communicate both developing safety concerns and decisions amongst regulatory authorities before they are made public, a secure web-based communication system should be developed.
3. Post-marketing risk management strategies for products identified as posing a significant risk at the time of initial evaluation should be developed.
4. Regulators should all have crisis management plans and test them regularly.
5. The utility of the WHO Adverse Drug Reaction Reports (ADR)- database should be strengthened by timely reporting of quality data by all participating countries.
6. The WHO ADR- database should be openly accessible to all stakeholders.
7. The special needs for assessing the effectiveness and risk of medicines used in the treatment of HIV/AIDS, particularly in developing countries should be considered a priority for WHO.
8. The current WHO Programme for International Drug Monitoring should be strengthened in its role as the mandated global pharmacovigilance system.