What else do Biotechs have to do with pharmacovigilance? First scene

Ms.
Mo Xiaoyao, a senior industry expert with more than 20 years of experience in pharmacovigilance, said that in reality, there have been clinical trial projects that have been stopped by the drug regulatory authorities of the United States, the European Union and China due to safety problems, and there are also cases where enterprises have to take the initiative to suspend
.

Under the trend of innovative drug development to explore multiple dimensions and seek a larger market space, a relatively unknown field, Pharmacovigilance, has begun to receive attention
with the increasing development of laws and regulations and the increase of foreign cooperation and business activities in innovative drug development.

Kangfang's joint venture with Chia Tai Tianqing, Tianqing Kangfang's pharmacovigilance project, has just recently passed regulatory verification
.
The R&D customers also learned that Hengrui Pharmaceutical, BeiGene, Cinda Biological, Junshi Biological, Yasheng Pharmaceutical, Kangfang Bio and other leading innovative drug companies have set up pharmacovigilance departments very early, ranging from more than 30 people, and constantly introduce experienced pharmacovigilance commissioners, doctors and legal affairs and other relevant personnel to track, supervise and report
important adverse drug reactions.

Ms.
Mo Xiaoyao, a senior industry expert with more than 20 years of experience in pharmacovigilance, said that in reality, clinical research has been suspended by the regulatory authorities of the United States, the European Union and China due to safety issues, and the importance of pharmacovigilance to the whole process of new drug development is self-evident
.

"Pharmacovigilance in China is just getting started, but it's been evolving
.
Especially with the acceleration of international development such as global multi-center clinical and foreign cooperation transactions, enterprises and regulatory authorities have paid more and more attention to pharmacovigilance, and the requirements and quality have become more and more stringent
.
Dr.
Ni Xiang, senior vice president of Kangfang Biologics, said
.

Performance responsibilities must be clearly demarcated

In recent years, BeiGene has reached a number of foreign trading cooperation, the most notable of which is the licensing agreement with Novartis on December 21 last year to jointly develop, produce and commercialize BeiGene's TIGIT inhibitor ociperlimab in North America, Europe and Japan.
In addition, BeiGene was granted the right
to sell 5 approved Novartis anti-tumor drugs in China.

"In the process of cooperative transactions, the two parties not only sign a commercial contract, but also need to sign a pharmacovigilance agreement to clearly
distinguish their respective pharmacovigilance performance responsibilities.
" Dr.
Wang Lai, President of Global R&D at BeiGene, told the developer
.

Dr.
Wang Lai believes that in addition to comprehensively evaluating the efficacy of the trading varieties, it is also necessary to fully consider their safety and the pharmacovigilance knowledge and capabilities of their partners, and if they can do a good job in building a pharmacovigilance quality system related to drug safety before the start of commercial activities, and clarify their respective rights and interests, it will reduce the loss
of benefits due to the failure to objectively assess drug safety risks in a timely manner.

Specific to the cooperative transaction process, Ms.
Zhang Yijing, executive director of global pharmacovigilance and head of pharmacovigilance in China, believes that these aspects need to be considered: examining the cost of safety risk management, the strength of evidence on potential safety issues, whether there are special concerns from regulatory authorities because of safety issues (it is recommended to refer to similar products); Examine whether there is a record of safety non-compliance (pharmacovigilance work has not been carried out in accordance with regulatory requirements) or defects found in the inspection process of regulatory authorities from the development of the product to the market; Conduct pharmacovigilance system and capability assessment before cooperation, not only in the daily record and file
.

Part of the previous cases experienced by Ms.
Mo Xiaoyao are due to the lack of pharmacovigilance agreements and the need to supplement and amend ongoing commercial cooperation contracts
.
"In our corrective technical support work after the fact, most of them are due to the fact that the two parties to the contract did not consider the pharmacovigilance system, implementation, compliance and other factors in advance, and after the completion of the contract, during the performance of
the contract by both parties, due to unclear or non-compliance of responsibilities and rights, etc.
, resulting in great losses and then corrected or compensated.
" Ms.
Mo Xiaoyao is currently the founder of Beijing Xinan Jiakang Medical Technology Co.
, Ltd.
and a medical and equipment vigilance consultant
.

She compares business cooperation and evaluation to marriage: both sides must not only maintain a high enthusiasm for the benefits of business cooperation, but also in scientific activities, both sides continue to carefully examine each other's quality, ability, and future assessment, and even have their own estimates, which also stem from evidence and performance, and pharmacovigilance is one of the
manifestations.

In particular, she reminded that pharmacovigilance runs through the entire life cycle of drugs, when there is a stable and reliable pharmacovigilance system in operation, there may be evidence of safety, and the system does Gideon for the continuous recognition of drug safety, and preventing the occurrence of unnecessary risks is one of the tasks of
the pharmacovigilance system.

"Taking reasonable steps to avoid risks outweigh benefits, which is also the core of
pharmacovigilance risk management.
" Pharmacovigilance due diligence should also be an important consideration in a two-party collaboration or 'marriage'
.
Mo Xiaoyao said
.
How to maximize the win-win situation between the two sides in combining key issues such as resources, capabilities, and compliance is the first issue to be considered in the implementation level of the pharmacovigilance strategy, which requires the review and support
of experienced and professional pharmacovigilance personnel.

"A good business cooperation, from understanding, mapping to negotiation and communication, to the conclusion, BD personnel need to work closely with the scientific research and development team, and here is also indispensable to the support and contribution
of pharmacovigilance professionals.
" Mo Xiaoyao said
.

In addition, attention needs to be paid to the provisions and compliance of responsibilities, rights and obligations related to pharmacovigilance clauses in commercial transfers and cooperation
.
For example, some authorized transfers will have market segmentation, with their respective teams responsible for different jurisdictions and regions, and the corresponding pharmacovigilance responsibilities must be defined
in advance in accordance with local laws and regulations.
Mo Xiaoyao said: "If one party's pharmacovigilance comprehensive ability is strong, it can continue to undertake more future pharmacovigilance work
.
" During the cooperation period, the other party must also fulfill its own pharmacovigilance responsibilities in the contract between the two parties, and at the same time, the two sides can also carry out timely interconnection on the important issues of pharmacovigilance, at least at the pharmacovigilance compliance level, do not drop the chain
.
”

Zhang Yijing also agrees with Mo Xiaoyao's view that when signing a pharmacovigilance agreement, it is necessary to clarify the responsibilities and obligations of both parties, and according to the rights and interests of both parties in different regions, it is necessary to determine the ownership of safety data, which party will make security decisions, especially who is responsible for communicating and submitting
to the regulatory authorities.

Hengrui Pharmaceutical, which is active in project transfer and external cooperation, attaches great importance to the transparent communication
of existing safety data and product safety.
At the same time, "clarify the division of responsibilities for pharmacovigilance between the two sides in the later stage of cooperation, including but not limited to the exchange of safety data between the two parties, the requirements for regular review, and timely communication of important discoveries
.
" Dr.
Zhan Xiaojing, head of pharmacovigilance at Hengrui, said
.

Global integration of regulation

Just as global development is integrated, Li Maozhong, deputy director of the Department of Drug Registration of the State Food and Drug Administration, mentioned that "pharmacovigilance is also globally integrated"
.
Last year, China issued the "Pharmacovigilance Quality Management Specification", which clearly requires domestic and
foreign holders to establish a drug safety committee for overseas pharmacovigilance.

Since the State Food and Drug Administration joined ICH in 2017, there is still a lot of way to go
in the implementation of the ICH E2 series of secondary guidelines.
The Pharmacovigilance Quality Management Practice, drawing on the ICH E2 series of guiding principles and the experience of corresponding pharmacovigilance regulations, clearly requires that the holder should establish a drug safety committee and set up a special pharmacovigilance department, and its legal representative or main person in charge is fully responsible for pharmacovigilance activities, and
should designate a pharmacovigilance person in charge who meets the qualification requirements.
The clarity of regulations and guidelines is conducive to the establishment
of a pharmacovigilance system.

"The US FDA, the European EMA, the Japanese PMDA, the ICH, and the regulatory regulations of various countries on relevant pharmacovigilance are almost the same as the overall goal of pharmacovigilance, that is, it needs to be responsible for public health and drug safety, which also needs to be based on
the normal operation of the pharmacovigilance system.
" Mo Xiaoyao said
.

At present, although the State Food and Drug Administration has no clear requirements
for who is responsible for pharmacovigilance in overseas MAH.
Companies with overseas operations are wondering: Does it have to be a resident in China? Ms.
Moon Young-sook of Spring Pharma Japan Office believes that people who are resident abroad and meet the requirements of the Quality Management Practice for Pharmacovigilance may also be appointed as the head of pharmacovigilance if they have the
ability.
In this regard, Mo Xiaoyao also agreed very much: "Under the new crown epidemic, as long as the pharmacovigilance system is perfect enough, PV personnel ability and professionalism meet the requirements of
regulations, no matter where they are located, it is the first thing to be able to do things.
" Geography is no longer a boundary
.
”

It is foreseeable that with the improvement of domestic requirements and attention to the quality of pharmacovigilance, Biotech has carried out more licensing transactions, and pharmacovigilance will be the basic subject
of China's Biotech and regulatory research and development.