Scheduling of Registration and Renewal Committee Sessions REF#6089

30 May 2024 | Healthcare Issue Tackled

Last modified date: 30 May 2024

Issue Description

The decisions on medical product registrations and renewals take place during the Ministry of Health’s committee sessions. This committee receives all relevant documentation required from the applicant beforehand to be reviewed before making a decision on whether to approve a product’s application. As these meetings are a necessity for the approval process of all medical products in Cambodia, they are of the utmost importance for the functioning of the healthcare sector. While the Department has confirmed that the committee intends to meet five to six times per year, the compliant private sector believes that if the committee could meet with more frequency, Cambodia’s healthcare system could respond to the needs of patients more effectively as product applications would be processed more efficiently.

Impact on business

Prolonged product registration and renewal processes make it more difficult for healthcare companies to do business in Cambodia and negatively impacts prospective investors’ perceptions of the market. More importantly, delays in product registration and renewal can prevent vital, life-saving medicines and equipment from entering the country. If the Ministry’s registration and renewal committee was able to commit to meeting more frequently than 6 times per year, it would enable healthcare companies to better coordinate their applications and help reduce the reoccurring product registration and renewal delays.

Recommendation

  • Hold registration and renewal committee sessions at least once per month.

While EuroCham recognises the difficulties involved in the coordination of multiple committee members, we would encourage the Ministry of Health to hold registration and renewal committee sessions more frequently than six times per year. We suggest meeting at least once per month, for a total of 12 meetings per year. While we expect that this decision would be dependent on the schedules of committee members, we feel that it would be most beneficial if the sessions could be held at least once per month to provide the greatest opportunity to process applications.

We also believe that if the schedule was set and published for the year ahead, committee members could accommodate their schedules according to these meetings, as they are of the upmost importance to patients in Cambodia. Through doing so, the Ministry would support the industry to bring more innovative and life-saving treatments to Cambodia more efficiently, thus improving the overall healthcare system and quality.

Dialogue with

Royal government of Cambodia

Initiative from Eurocham: The issue has been raised by the Healthcare Committee within The White Book edition 2024 in the Recommendation No. 48.

At the occasion of a meeting with the Department of Drugs and Foods, EuroCham has been informed that the Ministry of Health will hold a registration and renewal committee session one time per month -the first friday of every month. 

National Counterparts

Ministry of Health