Public comments on the check points for drug marketing authorization holders

Recently, the State Food and Drug Administration issued the "Check Points for Drug Marketing Authorization Holders (Draft for Comment)" (hereinafter referred to as the "Draft for Comment")
.
According to the "Draft for Comments", the inspection points apply to the supervision and inspection of domestic drug marketing authorization holders (hereinafter referred to as "holders") who entrust the production of drugs
.
Under the new regulatory system, holders are responsible for the whole life cycle management of drugs.
The "Draft for Comment" highlights the responsibility of holders in the whole process of drug development, production, sales and use, and strengthens the quality control of holders.
In the production link, it extends to the sales and circulation link
.

 

The "Draft for Comments" systematically sorts out the relevant provisions of China's existing laws and regulations , and refers to the requirements of relevant international guidelines, from overall requirements, institutions and personnel, production management, material management, quality control and quality assurance, document and record management, sales management, pharmaceutical Post-marketing research and risk management, vaccine marketing authorization holders, and other requirements in a total of 10 aspects put forward the key inspection contents of the regulatory authorities for domestic holders of entrusted production of drugs, emphasizing the effectiveness of the relevant systems of holders and the system of entrusted enterprises articulate
.

 

In terms of general requirements, the "Draft for Comments" pointed out that holders should establish a quality assurance system covering the entire process of drug development, production, sales and use, continue to strengthen quality control and quality assurance capabilities, and legally regulate drug development, production, and sales.
, responsible for the safety, effectiveness and quality controllability of the whole process of use
.
The "Draft for Comment" proposes the holder's responsibilities in marketing release, entrusted production management, drug traceability, pharmacovigilance, etc.
, and requires the establishment of drug marketing release management procedures, drug traceability system, and pharmacovigilance system
.

 

　　In line with the holder's responsibility for the quality of the entire process, the "Draft for Comments" proposes that the holder should set up a management department with clear responsibilities and staff with management personnel that match the scale of the drugs it entrusts to produce
.
The established management department shall clarify the responsibilities of drug research and development management, production management, quality management, sales management, storage and transportation management, pharmacovigilance, post-marketing research, etc.
The quality management department shall be set up independently, participate in all quality-related activities, and shall not Responsibilities are delegated to other departments
.
The person in charge of the enterprise, the person in charge of quality, the person in charge of quality authorization, the person in charge of production, and the person in charge of pharmacovigilance of the holder shall be full-time personnel of the enterprise
.

 

　　The "Draft for Comment" strengthens the quality control responsibility of the holder in the production process, and the relevant regulations cover production management, material management, quality control and quality assurance, document and record management,
etc.
According to the "Draft for Comments", for the entrusted production enterprises, the holder should not only confirm its facilities and equipment, supervise the production process, review the process regulations, and conduct risk assessment of co-production, etc.
, but also establish a material supplier management system and management files.
, and provide the list of qualified suppliers to the entrusted production enterprises
.
The holder shall review the batch production records, batch packaging records, inspection reports and deviation handling and other related records of the products released by the entrusted manufacturer
.
The listing release responsibilities of the holder shall not be entrusted to the entrusted production enterprise
.

　　The "Draft for Comments" also covers sales management, entrusted storage and transportation, post-marketing research and risk management, production discontinuation reports, annual reports and liability compensation.
Audit, supervision and other quality control responsibilities
.
In terms of liability compensation, the "Draft for Comments" proposes that the holder should have the liability compensation capability required by law, establish relevant management procedures and systems for liability compensation, and implement the first responsibility system for compensation
.
(Yan Ruoyu)

　　Recently, the State Food and Drug Administration issued the "Check Points for Drug Marketing Authorization Holders (Draft for Comment)" (hereinafter referred to as the "Draft for Comment")
.
According to the "Draft for Comments", the inspection points apply to the supervision and inspection of domestic drug marketing authorization holders (hereinafter referred to as "holders") who entrust the production of drugs
.
Under the new regulatory system, holders are responsible for the whole life cycle management of drugs.
The "Draft for Comment" highlights the responsibility of holders in the whole process of drug development, production, sales and use, and strengthens the quality control of holders.
In the production link, it extends to the sales and circulation link
.

 

　　The "Draft for Comments" systematically sorts out the relevant provisions of China's existing laws and regulations , and refers to the requirements of relevant international guidelines, from overall requirements, institutions and personnel, production management, material management, quality control and quality assurance, document and record management, sales management, pharmaceutical Post-marketing research and risk management, vaccine marketing authorization holders, and other requirements in a total of 10 aspects put forward the key inspection contents of the regulatory authorities for domestic holders of entrusted production of drugs, emphasizing the effectiveness of the relevant systems of holders and the system of entrusted enterprises articulate
.

 

　　In terms of general requirements, the "Draft for Comments" pointed out that holders should establish a quality assurance system covering the entire process of drug development, production, sales and use, continue to strengthen quality control and quality assurance capabilities, and legally regulate drug development, production, and sales.
, responsible for the safety, effectiveness and quality controllability of the whole process of use
.
The "Draft for Comment" proposes the holder's responsibilities in marketing release, entrusted production management, drug traceability, pharmacovigilance, etc.
, and requires the establishment of drug marketing release management procedures, drug traceability system, and pharmacovigilance system
.

 

　　In line with the holder's responsibility for the quality of the entire process, the "Draft for Comments" proposes that the holder should set up a management department with clear responsibilities and staff with management personnel that match the scale of the drugs it entrusts to produce
.
The established management department shall clarify the responsibilities of drug research and development management, production management, quality management, sales management, storage and transportation management, pharmacovigilance, post-marketing research, etc.
The quality management department shall be set up independently, participate in all quality-related activities, and shall not Responsibilities are delegated to other departments
.
The person in charge of the enterprise, the person in charge of quality, the person in charge of quality authorization, the person in charge of production, and the person in charge of pharmacovigilance of the holder shall be full-time personnel of the enterprise
.

 

　　The "Draft for Comment" strengthens the quality control responsibility of the holder in the production process, and the relevant regulations cover production management, material management, quality control and quality assurance, document and record management,
etc.
According to the "Draft for Comments", for the entrusted production enterprises, the holder should not only confirm its facilities and equipment, supervise the production process, review the process regulations, and conduct risk assessment of co-production, etc.
, but also establish a material supplier management system and management files.
, and provide the list of qualified suppliers to the entrusted production enterprises
.
The holder shall review the batch production records, batch packaging records, inspection reports and deviation handling and other related records of the products released by the entrusted manufacturer
.
The listing release responsibilities of the holder shall not be entrusted to the entrusted production enterprise
.

　　The "Draft for Comments" also covers sales management, entrusted storage and transportation, post-marketing research and risk management, production discontinuation reports, annual reports and liability compensation.
Audit, supervision and other quality control responsibilities
.
In terms of liability compensation, the "Draft for Comments" proposes that the holder should have the liability compensation capability required by law, establish relevant management procedures and systems for liability compensation, and implement the first responsibility system for compensation
.
(Yan Ruoyu)