New regulations | Eight considerations for the construction of the MAH pharmacovigilance system

On May 13, 2021, the State Food and Drug Administration issued the “Announcement of the State Food and Drug Administration on Issuing the Pharmacovigilance Quality Management Standards” (No.

With the issuance and implementation of the revised Drug Administration Law in 2019, the restructuring of China's legal and regulatory system has gradually begun.

In order to help each MAH build and improve a management system that complies with the 2021 version of the "Pharmacological Vigilance Quality Management Code", the author recommends that the MAH management team consider and carry out its work from the following eight aspects.

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Article 24: The person in charge of pharmacovigilance should be a manager with a certain position, should have a medical, pharmacy, epidemiology or related professional background, a bachelor degree or above, or an intermediate or above professional title, and have been engaged in pharmaceuticals for more than three years Vigilance related work experience, familiar with my country's pharmacovigilance related laws and regulations and technical guidelines, and possess knowledge and skills in pharmacovigilance management.

In the draft of the "Pharmacological Vigilance Quality Management Regulations" released in 2020, it is required that the person in charge of pharmacovigilance should be the senior management of the enterprise; in the current finalized document, the word "high-level" has been deleted.

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Judging from the above specifications, the pharmacovigilance department should be an independent department so that it can reflect the special organizational features mentioned in the specifications.

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◆Plans and system documents

---Pharmacovigilance internal audit program

---Internal audit records of pharmacovigilance work

---Post-marketing safety research program

---CT stage, need to have a clinical trial plan

---Pharmacovigilance Commission Agreement

---Pharmacovigilance audit report

---Pharmacovigilance system master file

---Regular security update report

---Pharmacovigilance plan

◆Pharmacovigilance procedures and record documents

--- Appointment

---Job Responsibilities

---Pharmacovigilance Annual Report System

---Pharmacovigilance entrusted management system

---Pharmacovigilance training system (and GMP training system can be combined)

---Pharmacovigilance CAPA procedures (and GMP related procedures can be combined)

---Responsibilities of the Drug Safety Committee

---Drug Safety Committee Management System

---Information system management system

---Information system operating procedures (covering multiple procedures)

---Individual adverse drug reaction report procedures

---Pharmacovigilance risk management procedures (can be combined with GMP related procedures)

---Pharmacovigilance quality target procedures

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What are the characteristics of the pharmacovigilance system established by MAH?

According to Article 8 of the 2021 version of the "Pharmacological Vigilance Quality Management Code": Holders shall incorporate the key activities of pharmacovigilance into the quality assurance system for the purpose of risk prevention and control, focusing on the following:

(1) Set up a reasonable organization;

(2) Equipped with personnel, equipment and resources required for pharmacovigilance activities;

(3) Formulating a management system that meets the requirements of laws and regulations;

(4) Formulate comprehensive, clear and operable operating procedures;

(5) Establish effective and unblocked information collection channels for suspected adverse drug reactions;

(6) Carry out reporting and disposal activities that meet the requirements of laws and regulations;

(7) Carry out effective risk signal identification and assessment activities;

(8) Take effective control measures against the identified risks;

(9) Ensure that documents and records related to pharmacovigilance are available, accessible, and traceable.

It can be said that the above requirement states all the characteristics of a good GVP system that MAH should establish.

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How to compile the annual report of pharmacovigilance?

On November 29, 2019, the National Food and Drug Administration ADR issued the "Notice on Issuing Guidelines for the Preparation of Pharmacovigilance Annual Reports for Drug Marketing Authorization Holders (Trial)".
MAH should compile a pharmacovigilance annual report based on the requirements of this regulation.

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What requirements need to be met when pharmacovigilance is entrusted to other companies?

According to the requirements of the 2021 version of the "Pharmacological Vigilance Quality Management Code", if MAH wants to delegate the pharmacovigilance work to other legal persons, it needs to meet the following requirements:

to sum up

In summary, MAH needs to comply with the latest pharmacovigilance regulations and norms.
It is hoped that the MAH will actively prepare and plan during the transition period set by the national bureau, and build a compliant and reasonable GVP management system as soon as possible in accordance with regulations and various supporting guidance documents.