TOWARDS AN INTEGRATED APPROACH IN PHARMACEUTICAL REGULATORY INFORMATION MANAGEMENT: PRISM@HSA

Link to the PRISM website: http://www.hsa.gov.sg/prism

The Singapore Health Sciences Authority (HSA) was among the top 100 organisations honoured with CIO 100 Award at the 4th annual awards competition hosted by CIO Asia Magazine. The award was for having achieved excellence in strategic enterprise IT deployment using the Pharmaceutical Regulatory Information System (prism@hsa).

prism@hsa has significantly remodelled the existing regulatory application and licensing approach by functioning as an end-to-end system. It supports the licensing of western medicines, Chinese proprietary medicines, health supplements, cosmetic products, clinical drug trial approvals, tobacco retailers, pharmacies, as well as product manufacturers, assemblers, importers and wholesalers.

Designed as a comprehensive one-stop online portal, prism@hsa's fundamental purpose is to simplify the paper-based approach, which had involved manual inputs from multiple parties in the past. In so doing, it has dramatically speeded up the conventional licensing process.

Clients now have the convenience to submit electronic licence, permit and certificate applications directly to the Centre for Drug Administration (CDA) on a 24x7 basis.

Key System Features
1) Seamless communication via the integrative processing feature
The integrative processing feature facilitates the preparation of applications through the use of code tables and copy functions. This aids in the end-to-end application submission and evaluation processes of licenses, permits and certificates in a paperless environment.

prism@hsa allows for pre-validation of applications so that applications are checked through before submission. HSA staff can annotate documents in question and route the amended documents to applicants for online re-submission. This interactive communication process between clients and staff saves time for resubmitting applications and removes the need for filing.

Clients are also able to track the status of their applications. Once an application is approved, clients will be notified via email, short-messaging-service (SMS), or fax. Together with the approval, the accompanying licensing details will also be made available online.

With prism@hsa, clients can now conduct online consultations with HSA officers on regulatory requirements.

The once convoluted procedure of obtaining numerous sequential endorsements for application of clinical trial certificates prior to CDA is now simplified with an integrated endorsement process, where endorsers are prompted via email to endorse applications at their convenience.

Integrated with the portal, iCall@hsa allows clients to make enquiries through the telephone on the status of applications using natural speech, in English. As the system provides clients with a list of licenses, permits or certificates issued by HSA, clients are able to renew, cancel, withdraw and amend their documents easily.

2) Closer collaboration with overseas users with secured authentication feature
The client registration and identification service (cris@hsa) allows overseas partners to prepare applications on behalf of their Singapore clients. Clients can now authorise overseas partners, employees and service providers to draft applications on their behalf. Overseas drafters are authenticated using the HSA PIN issued by HSA.

Overseas product manufacturers who want to keep the ingredients formula of their products confidential are able to submit this information electronically and securely without having to reveal the details to their local agents.

In addition, overseas partners and authorities are also granted the option to receive licenses, certificates and permits electronically. With this value-added feature, clients can now tap on prism@hsa to provide timely information on their behalf to overseas partners, thus saving time and cutting down additional expenses.

With the wealth of processing information captured by prism@hsa, the system can double up as an invaluable data repository for knowledge sharing, audit and enforcement purposes.

The change in mindset from the streamlining of existing work processes and embracing an integrated e-approach is resulting in major work improvements. The enhanced communication between clients and CDA as a result of the integrated processing feature has positively impacted operational efficiency. The greater accessibility to information through its varied delivery channels translates to timely information sharing and improved knowledge management for clients, public and CDA.

Challenges
One of the most challenging tasks faced by the team is implementing the integrated licensing system within 10 months. The rollout of the first module was within 4 months from start of development. CDA opted for a fast-track approach as a lengthy project schedule would substantially divert resources from the operational regulatory work and ongoing regulatory changes would make it difficult to finalise development. To meet the stringent system requirements, the deployment of adequate technological support including the provision of Chinese characters, scientific symbols, big file attachments, 2 layer encryption and re-submission of data and attachments were made available. While there are ongoing technical and operational issues that are being reviewed and refined in the roll-out process, the high level commitment from the IT team, CDA staff and also CDA's clients to make the system work is probably the most significant factor in ensuring its successful implementation.

Here's what Mr. Michael Wong, the Secretary of the Cosmetic, Toiletries and Fragrance Association of Singapore (CTFAS) has to say:

'I can track applications, whether they are in the stages of draft, pending approval, or approved. I can generate reports to show our Principals the work we had done. We can also save the attachments, like labels, ingredient lists electronically, saving on space. The system also has a feature to facilitate data entry of cosmetics colours formulas.'

For more information on prism@hsa, please refer to http://www.hsa.gov.sg/prism