Nirmatrevir+Ritonavir 150 mg+100 mg tablets(Zhejiang Huahai Pharmaceutical Co. Ltd.), CV016

WHOPAR Part 7

March 2024

Steps before prequalificationI.

BACKGROUND INFORMATION ON THE PROCEDURE

1. Submission of the dossier
The company Zhejiang Huahai Pharmaceutical Co., Limited submitted in 2022 an application for[CV016 trade name]* (CV016) to be assessed with the aim of including [CV016 trade name] in thelist of prequalified medicinal products for the treatment of coronavirus disease 2019 (COVID-19).
[CV016 trade name] was assessed according to the ‘Procedure for Assessing the Acceptability, inPrinciple, of Pharmaceutical Products for Purchase by United Nations Agencies’ by the team ofWHO assessors. The assessors are senior experts, mainly from national authorities, invited by WHO
to participate in the prequalification assessment process.
2. S20teps taken in the evaluation of the product*October 2020

A desk review for evaluation of compliance of the manufacturer of one FPP for GMP wasconducted and it met WHO requirements.

November 2022

During the meeting of the assessment team the safety and efficacy data were reviewed andfurther information was requested

December 2022The assessment team reviewed the quality data and further information was requested.

January 2023

The applicant’s response letters were received.

January 2023

During the meeting of the assessment team the additional quality data were reviewed andfurther information was requested.

February 2023

The applicant’s response letter was received.

March 2023

During the meeting of the assessment team the additional quality data were reviewed andfurther information was requested.
The safety and efficacy data were reviewed and found to comply with the relevant WHO
requirements.

March 2023

The applicant’s response letter was received.

March 2023

During the meeting of the assessment team the additional quality data were reviewed andfurther information was requested.

April 2023

The applicant’s response letter was received.

May 2023

During the meeting of the assessment team the additional quality data were reviewed andfurther information was requested.

July 2023

The applicant’s response letter was received.

July 2023

During the meeting of the assessment team the additional quality data were reviewed andfurther information was requested.

July 2023

The applicant’s response letter was received.

July 2023

During the meeting of the assessment team the additional quality data were reviewed andfurther information was requested.

July 2023

The sites relevant for the bioequivalence study were inspected for compliance with WHO
requirements for GLP and GCP.

Trade names are not prequalified by WHO. This is the national medicines regulatory authority’s responsibility.
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Nirmatrevir+Ritonavir 150 mg+100 mg tablets(Zhejiang Huahai Pharmaceutical Co. Ltd.), CV016

II.

WHOPAR Part 7

March 2024

August 2023

The applicant’s response letter was received.

August 2023

The additional quality data were reviewed and further information was requested.

August 2023

The applicant’s response letter was received.

August 2023

The quality data were reviewed and found to comply with the relevant WHO requirements.

August 2023

Product dossier accepted (quality assurance)

December 2023

A desk review for evaluation of compliance of the manufacturer of the API for GMP wasconducted and it met WHO requirements.

December 2023

A desk review for evaluation of compliance of the manufacturer of one FPP for GMP wasconducted and it met WHO requirements.

18 December 2023

[CV016 trade name] was included in the list of prequalified medicinal products.

GENERAL CONDITIONS FOR THE PREQUALIFICATION

1. Manufacturer and Inspection status
Manufacturer of the finished product and responsible for batch release
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao Linhai
Zhejiang 317 024
P.R.China
Inspection status
A desk review for evaluation of compliance of the manufacturer of APIs and FPPs for GMP wasconducted and it met WHO requirements.
The sites inspected were found to be in compliance with WHO requirements for GLP and GCP.
2. (Advice on) Conditions or restrictions regarding supply and use
Medicinal product subject to medical prescription.
Further information is available at:https://extranet.who.int/prequal/medicines/prequalified/finished-pharmaceutical-products

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