Although much of the work has been done in Hong Kong, clinical trials on humans will begin in 2026 in mainland China, with the team hoping to establish clinical research collaborations in the United States too.

Before a drug can be used in Hong Kong, it must already be registered in at least two of the 36 countries specified by the Department of Health, a list that includes the US and China.

Ma suggested the requirement slowed down medical innovation in Hong Kong and said that more clinical trials could be carried out locally and drugs approved faster once the city had its own drug review system.

A local approval system is coming. Authorities plan to set up the Hong Kong Centre for Medical Products Regulation in the 2026-27 financial year, tasking it with conducting primary drug approvals.

They established a preparatory office in June, and it will engage local and overseas experts to support the development of the new centre while also possibly arranging for staff to receive training, health authorities have told the Post.

Experts say giving Hong Kong its own power to approve drugs would go a long way towards turning the city into a health and medical innovation hub as leader John Lee Ka-chiu outlined in his policy address last October.

Putting Hong Kong on that track would also help meet Beijing’s plans to position Hong Kong as a global centre for innovation and technology.

While experts generally supported the government’s ambitions, they cautioned that Hong Kong was short of the specialised manpower needed for the multiple facets of drug testing, evaluation, approval and registration.

They said overseas talent would have to be imported while training should be ramped up to produce local professionals qualified in regulatory science.

The entire approval process would be more competitive, they added, if the time required for clinical trials and the overall registration process was cut, and biotech firms had more guidance for meeting local and overseas regulatory requirements.

Quicker access for patients

The city currently has observer status at an international council of drug regulators, and it could take eight to 10 years to become an official member, a sign of recognition by other countries.

“If we could do our own assessment, we could take action immediately,” Wong said. “[Registration of] locally developed products would also be much faster.

“We could use local patients for our research and medications could be launched in Hong Kong as soon as possible.”

His estimation was based on the current time frame where the US generally needed six months to one year to approve a drug, and the European and Hong Kong authorities each needed about a year for their green light.

Chan said that a quicker local registration also meant that the drugs could be included on the list of medications used in public hospitals faster than before, and patients could use those drugs with government subsidies.

Drugs not yet registered in Hong Kong can be used for specifically named patients under special circumstances, but they usually will need to cover the costs, which could be tens of thousands of Hong Kong dollars each month.

Tsang Kin-ping, chairman of patients’ group Rare Disease Hong Kong, remained sceptical about whether patients would have earlier access to drugs. He said it would take time to see whether the city’s drug review system would be faster than the US Food and Drug Administration.

He also pointed out that pharmaceutical firms usually first filed their registration in the US market then Europe, and wondered if they would break the tradition and choose Hong Kong as the first location to register their products.

‘Boost to economy and status’

Experts expected that more clinical trials would take place in Hong Kong once the city launched its primary drug review system, which usually required drug applications supported by local research data.

Wong from HKU said that clinical trials would give healthcare professionals access to the most advanced technology and raise the standard of the professionals, who would need to have received extra training.

“For example, if we have to run a cancer study, doctors and nurses would need to get themselves familiarised with that latest treatment and its mechanism … naturally this could upgrade them with knowledge of the latest technology,” Wong said.

Sabrina Chan So-kuen, senior executive director of the Hong Kong Association of the Pharmaceutical Industry, said she expected that the launch of the primary drug review mechanism could help boost the development of the medical and healthcare industry by pulling in more financial resources.

“[Pharmaceutical firms] need to pay for medical professionals’ and research nurses’ man-hours,” Chan said, adding the industry would also cover costs related to research activities.

The association last year said that clinical trials had brought an estimated economic value of about HK$190 million a year to Hong Kong in the previous decade.

A report by Our Hong Kong Foundation published last year also pointed out that investing in clinical trials could generate financial returns of eight times the initial amount, based on experience in the United Kingdom.

Its National Health Service in the 2018-19 financial year received £355 million from life science companies for clinical research, which generated £2.7 billion in gross value added, referring to the value of goods and services produced in a sector.

The ecosystem could also help create more job opportunities for talent in biomedical science.

“When there is cutting-edge science in the healthcare system, more people would need to be recruited,” Wong said. “If a drug is launched, pharmaceutical firms would also need people to do monitoring and marketing … a group of scientists could also work together.”

CUHK’s Chan believed that Hong Kong would truly become a medical hub once it had the power to review others’ data and influence the pharmaceutical industry to follow the city’s standards.

Short of the right experts

But to make the system work, Hong Kong would need to have the right people, experts said.

“As we have never done primary reviews before, we don’t have any talent in areas of education, training and manpower planning,” said Henry Yau Kwong-chi, managing director of the Clinical Trials Centre at HKU. “There is an obvious gap in talent in this professional area.”

He said Hong Kong did not have enough people familiar with regulatory science, which covered developing new tools, standards and approaches, to assess the safety and performance of products.

Not many of the city’s scientists and researchers were familiar with the requirements of regulators such as the US FDA or China’s National Medical Products Administration, he added.

Wong and CUHK’s Chan said the city would also need clinical or pharmaceutical assessors familiar with toxicology to review applications, and administrators trained to support the drug review process.

But Chan noted Hong Kong already had a good foundation and even without its own primary drug review mechanism was active in conducting clinical trials. HKU and CUHK, home to the city’s two medical schools, had their own clinical trial centres too.

Clinical trial data from the city was also recognised by key global regulatory bodies such as the FDA.

“Our healthcare system is very sophisticated despite insufficient resources,” he said. “Our doctors’ standards, knowledge and ethics in scientific research, as well as our integrity and quality in conducting clinical trials, are globally recognised. Hong Kong is seen as a place with a high level of standards.”

New course anticipates demand

The experts agreed that running clinical trials and carrying out regulatory evaluations of new drugs required different expertise, and Hong Kong still needed to bring in talent to establish the new system and train locals.

HKU’s Wong said the city needed “someone senior from elsewhere” with the right expertise, while also nurturing local talent and providing them with a career pathway.

Programme director Karl Tsim Wah-keung, also chair professor at the life science division, said he and others in the biotech sector were disappointed that a Chinese-made Covid-19 drug, said to be as effective as Pfizer’s antiviral Paxlovid, was not allowed in Hong Kong because of a local requirement that a drug had prior registration in two other countries.

They recognised the need for specialists who understood the details of what was required to take a drug or medical device from the research and trial stage to approval for the market.

“Before the start of research, you need a person to know all this in order to find the right pathway to cut short your time and money,” Tsim said.

To help push for the establishment of the city’s own drug regulatory system, they hoped to play a role as an educator to help train talent to fill the gap, Tsim said.

HKUST’s year-long full-time programme costs HK$300,000 and will have about 30 students annually who will be trained in drug regulatory science and management, the requirements of various approval bodies, and safety in the development process.

CUHK’s pharmacy school said it also offered training in drug regulatory affairs, including an undergraduate course on laws and regulations related to pharmacy practice, and a postgraduate course on the regulation of advanced therapy products.

‘Being faster will pay off’

Speed mattered in clinical trials, and if Hong Kong offered a quick process that was considered competitive, more trials would be carried out and local talent would gain too, Sabrina Chan argued.

In Australia, researchers could start recruiting patients for a clinical trial in as little as two months after applying to authorities, whereas their counterparts in Hong Kong needed at least six months, she said.

She viewed clinical trials and the primary drug review mechanism as closely associated with the city’s biomedical ecosystem.

“Clinical trials are the prelude to the regulatory process, while regulatory approval looks at whether a clinical trial demonstrates efficacy and safety of a drug,” she said.

Yau from HKU said the future regulatory body could help guide companies in meeting local or international standards, much as the FDA did in the United States.

“If there is a drug you want to introduce to the US market, the FDA will offer very clear guidelines, and also very detailed, written advice,” he said.

Hong Kong would also gain from collaborating with mainland Chinese authorities in the drug approval process and help bring overseas products into the country, he said.

“The market in Hong Kong is too small,” he said. “If we establish capacity in the primary drug review, can we have a certain level of alignment or distribution of work with the country’s National Medical Products Administration?”

Lessons from Singapore

Regional rival Singapore introduced its own primary drug review system in 1998, known as the “full evaluation route”, and it is one of the pathways available for registering drugs in the city state.

Professor John Lim Chien Wei, founding executive director of Duke-NUS Medical School’s Centre of Regulatory Excellence, said that even after the full evaluation route was established, most drug products in Singapore did not go through the pathway because of the huge amount of resources and time needed.

Instead, most pharmaceutical products were registered through an “abridged route”, which meant they were approved by at least one overseas regulatory agency before coming to Singapore, Lim explained.

The bottom line, though, was that companies had a choice and establishing a quality regulatory regime could have an impact beyond a jurisdiction’s borders, he said.

Pharmaceutical firms that sought Singapore’s approval for their products were eyeing not just the local population of roughly 5.92 million but the more than 670 million people in all of Southeast Asia.

Lim, formerly CEO of Singapore’s medical products regulator, the Health Sciences Authority (HSA), said the country hoped to encourage more research, development and investment by setting up the primary evaluation pathway.

“If a company got its product approved by HSA in Singapore, then the likelihood of it being recognised, from a referencing point of view, by other regulatory agencies in the region would be stronger because they knew that Singapore’s system was robust,” he said.

“If Singapore approved it, they could also trust that the product was obviously safe, of high quality and efficacious.”