Singapore: Less Than Three Months Left For Companies To Prepare For New Pharma Rules

Singapore's Health Sciences Authority is alerting drug companies to the various procedural changes that they will have to prepare for and follow as of Nov. 1 to support the registration and sale of their products. These changes, which cover requirements relating to such thing as post-market surveillance, clinical trials and product advertising, will be introduced when the regulation of medicines is brought within the ambit of the Health Products Act.

While certain new procedures that the HSA is introducing are expected to result in regulatory simplification (e.g., faster authorization of clinical trials with locally registered therapeutic products used in accordance with approved labels), some of the new provisions will require companies to put new processes in place (e.g., naming a responsible person in the importer and wholesaler's licenses).

At present, medicines are regulated under the provisions of the Medicines Act and the Poisons Act. In order to update and streamline the regulatory control of health products, the HSA is transferring the legislative control of all pharmaceutical products to the Health Products Act, which originally only regulated medical devices. (Also see "New Drug Rules On Licensing, Trials, Surveillance Edge Closer In Singapore" - Pink Sheet, 18 Feb, 2016.)

To support this transfer, the HSA has issued several new regulations that will come into effect on Nov. 1. These regulations are: the Health Products Act (Amendment of First Schedule) Order 2016; the Health Products (Therapeutic Products) Regulations 2016; the Health Products (Clinical Trials) Regulations 2016; the Health Products (Therapeutic Products as Clinical Research Materials) Regulations 2016; the Health Products (Advertisement of Therapeutic Products) Regulations 2016; and the Health Products (Licensing of Retail Pharmacies) Regulations 2016.

While the fundamental regulatory regime for pharmaceutical products will remain the same under these new regulations, the HSA expects them to fine tune certain regulatory measures. The HSA is working on developing/updating several guidance documents to explain the new requirements (see Table 1).

According to the new regulations, some of the changes to be introduced include:

• Manufacturers of therapeutic products, ie currently holdsing a Manufacturer's Licence (ML), will no longer need a "Form A" poisons licence or an importer's licence to import starting materials, including active pharmaceutical ingredients (APIs), that are used for manufacturing their own own therapeutic products. Also, they will no longer need a wholesaler's licence for the wholesale of self-manufactured therapeutic products.
• The timelines for reporting product defects and adverse events (AEs) have been changed. Product defects that represent a serious threat will have to be reported within 48 hours and all others within 15 calendar days as opposed to the current requirement of reporting all defects within 24 hours regardless of whether the surfaced information may or may not lead to a subsequent recall of the product. All serious adverse reactions will have to be reported no later than 15 calendar days, compared with the current requirement of fatal and life-threatening AEs to be reported within seven calendar days and all others within 15 calendar days. Requirements relating to the maintenance of records, implementing risk management plans, submission of benefit-evaluation reports are not new, but these have now been formally legislated.
• For clinical trials, the existing system of the issuing clinical trial certificates (CTCs) will be replaced by a new risk-based process of issuing clinical trial authorization/clinical trial notification (CTA/CTN). Depending on the registration status of the investigational therapeutic product and whether its use in the clinical trial is in accordance with its approved label, a CTA are to be issued within 30 working days or a CTN within five working days. Under the current system, trial certificates are supposed to be issued within 30 working days. Also, as per the new regulations, observational clinical trials of pharmaceutical drugs and biologics will not require a CTA or CTN.
• The labeling requirements for investigational products have been refined to align with international requirements, and the HSA said there will "be a measured degree of flexibility in allowing for alternative approaches to traditional labelling requirements, provided the key principles of labelling are not compromised". The safeguards and consent requirements for the vulnerable subjects remain largely unchanged, except for clarifications to reflect the definition of legal representative defined under other applicable local legislation such as the Mental Capacity Act.
• The term "clinical trial material" is being replaced with "clinical research materials" to refer to any therapeutic product, medical device or medicinal product imported, locally manufactured or supplied for use in human clinical research. This will allow for a single, simplified regulatory regime regardless of the type of product imported/supplied or the type of human clinical research in which the product is to be used, thereby reducing the number of regulatory submissions. Also, the use of imported or locally-made clinical research materials will be permitted through a new notification system in place of the current process of seeking import approval.
• Companies will no longer need advertisement permits or sale promotion permits to advertise therapeutic products. Existing permits will longer be valid when the legislative control of therapeutic products is transferred to the Health Products Act. The HSA is advising companies to review their existing permits and to stop renewals for those that are not needed. The agency clarified that it will maintain its oversight of advertised products through the surveillance of the published advertisements.

Source: HSA

From the editors of Scrip Regulatory Affairs.