Though China still requires that foreign companies seek approval before using human genetic resources (HGR) in their clinical trials, a new regulation is relaxing the definition of ‘foreign entities’ and clarifying when approval is needed. This is intended to make it easier for biotech firms to start clinical trials.
On March 22, China’s Ministry of Science and Technology (MOST) issued its Draft Implementing Rules on the Administrative Regulations on Human Genetic Resources for public comment. This has been a long-awaited document ever since the Regulations on the Management of Human Genetic Resources came into effect in July 2019.
Fewer “foreign entities” and approvals
Under the new regulations, only companies or organizations whose foreign shareholders hold at least 50% shares are considered “foreign entities.” Currently, many local pharma companies can be defined as foreign parties just because they have foreign shareholders.
Obtaining approval from the MOST is not always needed as well.
When their clinical trials are for marketing drugs or medical devices in China, companies are not required to apply with the MOST to collect HRG for such trials.
Companies only need to seek approval when the collection of HGR involves important genetic families, resources from certain regions, or large population studies that enroll over 3,000 participants.
“Clinical trials for supporting product registration will no longer require HGR collection application and approval, which is undoubtedly a major move that will benefit drug development,” said Chang Jianqing, Vice President of Drug Regulatory Policy at Tigermed.
Faster initiation of multi-center trials
In another widely welcomed move, initiating multi-center clinical trials for the purpose of marketing authorization will be simpler.
The new regulation makes filing easier for clinical trials that do not involve transferring HGR out of China, as it can be done after the main party responsible for the trial obtains the ethical approval. Once the MOST receives a copy of the ethical approval and commitment letter, other institutions may initiate the clinical trials.
The new measures are expected to help save biotech companies their time and effort when initiating multi-center clinical trials, as companies often find the current filing process too complex.
However, a separate administrative approval is still required to initiate clinical trials that involve exploratory studies.
Less is more
The MOST also narrows down what types of HGR will need to be regulated.
The new regulation limits the definition of HGR data to human genes or genome data derived from HGR materials. Companies conducting clinical trials that use HGR data other than human genes or genome data will no longer need to file with the MOST.
“Data related to clinical practices, patient demographics, lab tests, medical images, etc. that do not carry genetic attributes will not be regulated as HGR data,” wrote law firm Ropes & Gray in a March commentary.
This is seen as an improvement as current regulation covers clinical data, imaging data, biomarker data, genetic data, protein data, and metabolic data. The broad scope of the definition adds to the burden of companies looking to initiate international multi-center clinical trials.
A knotty problem
Getting a nod from the MOST to collect HGR for clinical trials hasn’t been a smooth journey in China.
Between 2016 and 2020, China saw a threefold increase in HGR applications, according to data revealed by the Office of Human Genetic Resource Administration (OHGRA) at the 2020 DIA China Annual Meeting. OHGRA is under the MOST to regulate HGR.
The agency also revealed how hard it is to obtain approval, as only 50-60% of the applicants pass the pre-review stage. The high approval rates (as seen in the first chart) only reflect those who make it to the actual review stage.
“An important milestone”
The new regulations are set to help biopharma players, who often experience delays and hefty penalties.
BMS has already gotten a taste of it in China. In late 2020, the pharma giant’s contract research organization in China, ICON Beijing, was found forging documents for an IND filing with the MOST’s Office of Human Genetic Resource Administration. This resulted in the MOST halting HGR applications from BMS and ICON for six months and a year, respectively.
AstraZeneca, WuXi Biologics and BGI Genomics have also received penalties for sending HGR out of China illegally.
“Issuing the Draft is an important milestone in HGR management reform,” said Tigermed’s Chang.
She pointed out that simultaneous drug development across the globe has become an important strategy for drugmakers. The number of international multi-center clinical trials has been on the rise and is likely to continue growing.
“By implementing the new regulation in the future, global simultaneous development of new drugs will be further supported.”