18 February 2005

To: All Licence Holders

Guidance for Industry – Safety Reporting Requirements for Registered Medicinal Products

The Health Sciences Authority (HSA) has now published a guidance entitled: Guidance for Industry – Safety Reporting Requirements for Registered Medicinal Products. A copy of the guidance can also be found here.

2.  The objective of this guidance on safety reporting is to define the timelines and types of safety-related information/reports that should be submitted to the Pharmacovigilance Unit. The scope of the guidance covers the submission of the following documents:

(a) Spontaneous suspected ADR reports;
(b) Periodic safety update reports; and
(c) Regulatory actions or actions taken by companies due to safety issues

3.  In the establishment of the local safety reporting requirements, we have taken into consideration the requirements of other major regulatory agencies as well as the requirements of International Conference on Harmonisation (ICH). Comments and feedback from the industry have also been considered and incorporated where appropriate.

4.  Under Section 2 of the guidance, the licence holder is required to appoint a person to be responsible for matters relating to drug safety. We will appreciate if the name and contact of the person appointed for your company can be provided to the Pharmacovigilance Unit using the form attached at Annex I. Please send the completed form via fax, e-mail or mail to the Pharmacovigilance Unit, by 28 March 2005.

Pharmacovigilance Unit
Centre for Drug Administration
Health Sciences Authority
11 Biopolis Way, #11-03 Helios, Singapore 138667
Tel: (65) 6866 3538; Fax: (65) 6478 9069
Email: HSA_drugsafety@hsa.gov.sg  

5.  We look forward to your cooperation and support in the implementation of the requirements to enhance drug safety in Singapore. Please familiarise with the requirements and if you need further clarification on the guidance and/or the reporting requirements, please send your enquiry to HSA_drugsafety@hsa.gov.sg