HSA embarks on new model to evaluate drugs

SINGAPORE: The Health Sciences Authority (HSA) is studying a new model to evaluate drugs and bring them in faster to the market.

The project called the New Drug development paradIGms programme (NEWDIGS) is done in collaboration with the Massachusetts Institute of Technology’s Centre for Biomedical Innovation.

This was announced at the Asia Regulatory Conference by the Drug Information Association and the International Federation of Pharmaceutical Manufacturers Association on Monday morning where an Memorandum of Understanding (MOU) was signed between Singapore and Dutch regulators to enhance patient access to safe and effective medicines.

Traditionally, before a drug comes into a market, it has to go through a few phases.

A large population about 3,000 to 4,000 is usually tested towards the last phase.

And if it is deemed unsuitable for this whole sample size, the drug is dropped altogether.

The drug may still work for a smaller population and so this new model aims to allow an earlier entry for this drug.

It will then be closely monitored in relation to that population.

HSA hopes that it could introduce more of these personalised types of medicines faster as the traditional drug development model can take up to 14 years before it enters the market.

HSA’s chief executive officer Associate Professor John Lim, said: "We can potentially bring in more products that may otherwise be lost. This will be a long term process. We are still looking for a suitable product to take through the system and we have to adjust our regulatory frameworks."

Assoc Prof Lim added: "We are hopeful that for certain types of drugs for specific population sub—groups, in Singapore’s context, that means more chronic disease issues. We hope HSA can work with our partners and pioneer a model like this for Singapore and the rest of the world."

— CNA/fa