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FAQs

What are the main features of the GVP?

The GVP is the first supporting document on PV following the revision of the "Drug Administration Law of the People’s Republic of China". It embodies the concept of lifecycle management and adheres to the principle of risk management for drugs, clarifying the primary responsibility of MAHs and sponsors for PV and aligning with the latest international developments in pharmacovigilance.

Pharmacovigilance System Master File (PSMF)

The GVP requires MAHs to establish and maintain a PSMF to describe the PV system and its activities. The MAH should continuously improve the PSMF based on the requirements of the GVP and the specific conditions of the enterprise's PV system. Regulatory authorities may request the PSMF when deemed necessary.

Frequency of PSUR submission for imported drugs

Imported drugs should submit PSURs based on their registration category and the Regulation's requirements.

For innovative new drug and improved new drug shall submit PSUR every year after first approval; and then submit PSUR every 5 years after first 5-years license renewal.

For other drugs, shall submit PSUR every 5 years except for those specially required by authorities.

PSUR shall be reviewed and approved by RPPV before submitted in National ADR Monitoring System. If there is any review opinion from system, should process and respond timely.

If the internal submission frequency set by the company or the Chinese requirement is higher, the higher frequency standard shall prevail.

The submission of multiple PSURs at once is not accepted.

What should MAHs focus on during internal audits as required by the GVP?

The internal audit refers to the MAH's review of its PV system and its operations. It is a process of continuous improvement and quality management.

The internal audit can be conducted independently by personnel designated by the MAH or by external personnel or experts. Regardless of the organizational approach taken by the MAH, the independence of the internal audit must be ensured. Internal quality control activities organized by the PV department are not considered part of the internal audit as required by the GVP.

The audit should focus on risk prevention, and include the key PV activities in the audit scope. Any issues identified should be promptly addressed and corrected to improve the PV system, in order to improve the effectiveness of PV system.

Can MAH submit PBRER instead of PSUR and what’s the specific requirements?

Yes, MAH can use PBRER to replace PSUR. According to the announcement (NMPA No. 2020/86) released in July 2020, PBRER can replace PSUR, and the format and submission deadline shall follow ICH E2C (R2) Periodic Benefits-Risks Evaluation Report, which means PBRER with reporting period no more than one year shall be submitted within 70 days since DLP and PBRER with reporting period more than one year shall be submitted within 90 days since DLP.

Which part of imported drug’s PSUR shall be translated into Chinese before submission?

Except for Line Listings and Summary Tabulations, all the other parts of PSUR shall be translated into Chinese and submitted with CCDS (Company Core Data Sheet) and original English version of PSUR.

Which date shall be the starting date for PSUR submission? If the submission is overdue, will PSUR be rejected by the system?

Usually globally speaking, it starts from IBD, but if no information about IBD then CBD (approval date in China). If you miss the deadline of PSUR submission, the National ADR Monitoring System will still accept the submission but it does not mean the report passes.

Normally the transnational corporations have global PV system, so can the QPPV from headquarter play the role of QPPV in China and does China NMPA require QPPV shall be reachable 24 hours?

In China, it’s called Responsible Person for Pharmacovigilance, which equals to QPPV. There is no specific requirement that only persons based in China can take the role of RPPV. But practically speaking, it is recommended to assign a person based in China to be local RPPV and keep contact available always so that authorities can reach the RPPV when necessary.

For transnational pharma corporations, can the drug safety committee from headquarter take the role for China?

It depends. Generally the Drug Safety Committee concerns the drug safety globally from an overall point of view, but some markets may have different features and requirements. Furthermore, according to article 20 of GVP, the DSC is responsible for significant risk’s judgement & determination, significant or emergency events’ solution, risk control decision-making and other important events related with pharmacovigilance. Significant events are normally very urgent and it is required to respond immediately accordingly. But HQ Safety Committee may not even have enough time to respond for emergencies. So, it would be better to have local Safety Committee. However, if the HQ can make sure that they can respond timely and the SOP is compliant with China requirement, it’s also feasible.

Yes. Per the Writing Guidelines for Drug Periodic Safety Update Reports, such changes must be detailed in Section (4) "Changes in Drug Safety Information." Where a global CCDS or RSI exists, compare the Chinese label with it and justify any discrepancies; if no such document exists, compare with labels from other countries and provide justifications and impact analyses.

List some examples for requiring submitting PSUR

Should safety information changes of imported drugs occurring in China be included in the PSUR?

Genrics, OTC, even approved drugs with long-term non-production shall submit PSUR.

No need to submit PSUR for API, in-vitro diagnostic reagent, Chinese medicinal materials and decoction pieces except for those products specially required by authorities.

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