Issue Description
In 2019, the Ministry of Health (MoH) inaugurated the new online platform, the Cambodia Pharmaceutical Online Registration System (CamPORS), through Prakas No.2387. CamPORS is a digital one-stop window to register the import and use of pharmaceutical products in the country, and to accelerate registration procedures for new pharmaceuticals and medical devices. Previously, registration applications had to be submitted in paper form to the Department of Drug and Food offices within the MoH.
EuroCham had previously called for the adoption of such an electronic registration system, and welcomed this new development.
According to the new procedures of the platform, businesses must first apply for the right to register and use the CamPORS online system. Once they have been granted access, they can apply (with the required supporting documents) for registration of pharmaceutical and other related (e.g. medical devices and cosmetics) products. Following a successful registration, the MoH will then issue pharmaceutical product registration certificates to individual companies.
Despite the expectation that the introduction of CamPORS would speed up registration times for pharmaceutical and related products, and thus provide a boost to the healthcare industry in Cambodia, it seems in reality that the platform has not lived up to its full potential.
Specifically, our Healthcare committee has collected evidence from private sector users that the platform is difficult to navigate, particularly when uploading documents. Moreover, there have been reports of private sector users seeing their registration status on CamPORS contradicted by MoH officials, which calls into question whether the MoH and private sector users are able to coordinate their operations on the platform.
A key requirement of an online system such as CamPORS is to enhance the usability and functionality of document submission and registration. An online platform needs to demonstrate clear benefits in terms of time reduction and facilitation of procedures compared to previous paper-based systems, in order to prove its worth to the public.
Impact on business
At the moment, with users reporting difficulties with the usability of the platform, it is uncertain whether CamPORS has won over the private sector as a viable alternative to paper-based procedures. Users are still reporting relatively long periods of time to register pharmaceutical products, although it is uncertain to what extent this depends on the technical state of the platform itself or whether it depends more on its coordination with MoH activities. In any case, long registration times risk dampening the growth of Cambodia’s pharmaceutical market.
Recommendation
- Consult with the private sector to enhance the usability of CamPORS for product registrations.
To ensure that the digital opportunity of CamPORS is fully realised, EuroCham’s Healthcare committee stands ready to consult with MoH technicians and other members of the private sector to report on technical issues on the platform and suggest ways to improve it.
We therefore respectfully ask for a consultation meeting with MoH to discuss ways forward on the usability of the CamPORS platform.
With the recommendations coming from this consultation, we assure the MoH that it will have valuable information to push through much-needed enhancements to the CamPORS portal. We anticipate that most of these changes will take little time to implement, at low cost, and with great benefit to all users.
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. 44.
On 23 June, EuroCham convened PPSD-4 to review the progress made since PPSD-3. During the meeting, EuroCham raised the remaining actions required to resolve the Redundancy in Regulatory Approval of medicines and Recognising Stringent Regulatory Authority (SRA) by the Healthcare Committee.
During the meeting, CDC has requested the Ministry of Health to study this matter and explore facilitation to reduce redundant inspections and expedite approvals, given that these medicines already carry quality recognition from Stringent Regulatory Authorities (SRA).
CDC also suggested where existing precedent on foreign regulatory approvals are recognised under a trade agreement, this could be extended to the recognition of other SRA such as the European Medicines Agency (EMA), and committed to raising this directly with the Minister of Health.
MoH acknowledged EuroCham’s recommendations on SRA recognition and abridged pathway registration. In partnership with the Techo Startup Center, MoH targets launching the Health Service Registration System (HSRS) portal in 2027.
EuroCham will continue to engage with MoH to ensure the new portal is built with the legal basis to formally recognise SRA approvals and includes a dedicated abridged pathway from the outset.
National Counterparts
Ministry of Health