HSA: APAC’s Regulatory Gold Standard

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As the most important pharma hub in its region, and one of the most important globally, many companies look to launch new products in Singapore first before expanding to other markets. This situation keeps the Health Sciences Authority (HSA) – the country’s regulatory body – extremely busy. While challenges, including a lack of speed and regional regulatory harmonisation, exist, most industry actors in Singapore are full of praise for the work that the HSA does and its willingness to facilitate Singaporean patients’ access to innovation.

 

HSA CEO Dr Choong May Ling, Mimi, explains the country’s positioning within the Asia-Pacific region thusly: “As a small country, we are fortunate to be well located to reach markets in the region and beyond. Singapore’s regional and global connectivity, pro-business environment and strong talent pool, coupled with its well-regarded healthcare infrastructure, have created a strong value proposition to attract and anchor healthcare and life sciences companies in Singapore. As a regulator, we are seeing more and more companies keen to set up and license pharma and medical device manufacturing plants and apply for marketing authorisation for their health products here.”

 

Efficient, Engaged, and Transparent…

Some industry stakeholders, including MSD’s Ashish Pal – whose remit includes Singapore, Malaysia, and Brunei and who also sits as president of the Singapore Association of Pharmaceutical Industries (SAPI) and VP of the Pharmaceutical Association of Malaysia (PhAMA) – are effusive in their praise for the work of the HSA. “In our view, the HSA does a terrific job, characterized by high levels of engagement, transparency and dialogue,” he proclaims.  “In terms of regulatory efficiency, i.e., the turnaround times for new drug applications or new indication applications, from our experience, they have generally been even faster than the published timelines. The evaluation times of approximately 270 working days for the full NDA route or 180 working days for an abridged NDA route are also adhered to.”

 

As a regulator, we are seeing more and more companies keen to set up and license pharma and medical device manufacturing plants and apply for marketing authorisation for their health products here.

Choong May Ling, Mimi, HSA

 

Vincent Ruland, country division head for Bayer Pharmaceuticals Malaysia, Singapore, and Brunei, is also keen to play up the regulatory environment in Singapore. He states, “The HSA is very collaborative, and we have had great experiences with them. They are also well-connected with international regulatory agencies so there is a lot of regulatory harmonization there, which helps us bring medicines to patients faster and more efficiently.”

Pal adds that the HSA’s levels of performance have remained high in the past year, even in the face of the COVID-19 pandemic. “What has been really impressive is that [the HSA] has maintained this efficiency throughout 2020, despite the pandemic, which is testament to their leadership and operations. As one example, through the ongoing COVID-19 pandemic, companies have been able to submit real-time data for COVID-19 vaccines while the HSA conducts its regulatory reviews in parallel, a clear reflection of high levels of agility and efficiency.”

Dr Choong expands on this point, noting that, “In December 2020, we introduced the Pandemic Special Access Route (PSAR) to facilitate early access to critical novel vaccines, medicines and medical devices during a pandemic, such as the current COVID-19 pandemic. Using PSAR, our evaluators are able to start reviewing the data of new vaccines, medicines and medical devices from the early stages of clinical studies, as and when real-time data is submitted by companies on a “rolling”, or staggered basis, instead of waiting for the full data set to be submitted before starting our evaluation.

 

What has been really impressive is that [the HSA] has maintained [its] efficiency throughout 2020, despite the pandemic, which is testament to their leadership and operations

Ashish Pal, MSD

 

“This gives us more time to review the submitted data while companies continue with further clinical trials and development concurrently. Such regulatory agility and flexibility allow for speedier development and evaluation. To-date, interim authorisation under PSAR was granted for Pfizer-BioNTech and Moderna COVID-19 vaccines in Dec 2020 and Feb 2021 respectively to support Singapore’s fight against the COVID-19 pandemic. We were the first Asian country to authorise these vaccines.”

 

…But Slow and Regionally Isolated?

However, not everyone is quite so complimentary of the HSA. The country manager for a large European pharma manufacturer notes that while “the Singaporean authorities are very well connected internationally and work collaboratively with authorities in other countries, our experience in bringing innovation to market in Singapore thus far has been a mixed bag.” They continue, “The HSA has a lot on their plate, with many different companies attempting to bring their products to this visible and important market. They have a very stringent and structured process – as do all major regulators – which works like clockwork but does take time.”

 

While Singapore is seen as a gold-standard regulator regionally, there is so far no pathway for accelerated approvals in other countries based on a HSA approval

Vincent Ruland, Bayer

 

Other challenges include the HSA’s priority review routes, “implemented in 2017 to enhance our efforts on reviewing new and emerging medical devices designed and validated for unmet clinical needs in any of five focused healthcare areas of cancer, diabetes, ophthalmic, cardiovascular or infectious diseases,” according to Dr Choong. The same country manager adds that “while these expedited pathways have been beneficial for us, they are not necessarily available for every single product, so negotiations around the value of the product need to take place, which also take time. That particular timeframe is still quite fluid and ill-defined; more structure on negotiation timeframes would strengthen the pace at which innovation can be brought into Singapore even more.”

A further roadblock comes when attempting to take HSA approval and enter other countries in the region, many of which have wildly different levels of regulatory sophistication. “Within Southeast Asia there is much less regional regulatory harmonization [than there is between the HSA and more developed regulatory bodies globally],” admits Bayer’s Ruland. “While Singapore is seen as a gold-standard regulator regionally, there is so far no pathway for accelerated approvals in other countries based on a HSA approval, as far as I am aware. This, in particular, makes it tricky to enter smaller markets.”

 

“Global Collective Effort”

Despite these challenges, the HSA clearly has the support of industry stakeholders in Singapore, with the Authority’s intentions to accelerate the speed at which innovation can be brought into the country very visible. Moving forward, Dr Choong is keen to foreground the importance of greater collaboration – both locally and globally – to maintain this positioning. “It takes global collective effort among industry and regulatory bodies to ensure that healthcare institutions, patients and the public have access to safe, good quality, effective and timely health products,” she opines.

“Given our current dynamic operating environment and rapid scientific and technological advances, it is even more important now for regulatory bodies and the industry to work collaboratively. By strengthening trust and communications between different stakeholders, we can all work closely together to bring much needed health products to the market efficiently and effectively to achieve better health outcomes for all.”

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