Drug Evaluation Committee 2007-02 Obligation to Report Adverse Reactions to Over-the-Counter Drugs Adjunctively Used in Conjugation (Part 2)
Related classification: Report of adverse drug reactions, etc.
First published: August 2007
Revised publication date: December 2021
Question
Q&A listed in Clinical Trial 119 Official Position Paper, Question No. 2005-06,
The JPMA's opinion is that this is an appropriate response for a JPMA company. The Pharmaceutical Manufacturers Association of Japan (PMAJ) opinion states that this is an appropriate response for a pharmaceutical company, but we would like to ask for clarification on the following points.
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The SDV is a provision for clinical trials based on GCP that goes beyond the Medical Care Act and other regulations.
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A monitor is a specially appointed person in charge of clinical trial operations and cannot concurrently perform other duties as a monitor.
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If the information obtained through SDV by this monitor can be used as general information, is there no need for a special contract between the sponsor and Investigator Site regarding SDV?
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Is it conceivable that such information flow is stipulated in the SOP of the sponsor (or CRO)?
JPMA's Opinion
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SDV is stipulated as a responsibility of monitors in Ordinance No. 28 of the Ministry of Health and Welfare (GCP Ministerial Ordinance) based on the Pharmaceutical Affairs Law, and we believe that there is no light weight between SDV and other regulations such as the Medical Care Law.
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The requirements for monitors are stipulated in each company's monitoring procedures, etc., in accordance with Article 21, Paragraph 1, Guidance 3 of the GCP, and the GCP does not stipulate whether or not monitors can concurrently perform other duties. However, the duties of MRs, who belong to the sales department, and monitors, who belong to the development department, are quite different, and we believe that dual duties are undesirable.
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The agreement on SDV is based on Article 13 of the GCP, which confirms as a contract clause that the Investigator Site has consented to the inspection of source documents.
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Safety information related to clinical trials at Investigator Site is collected by monitors, and the sponsor is responsible for taking necessary actions. The handling of such safety information and how to respond to it are usually stipulated in the SOP of each company in accordance with the Pharmaceutical Affairs Law and related regulations.
As stated in the previous official opinion, pharmaceutical companies are obliged to collect information whenever they become aware of the occurrence of adverse reactions to their marketed drugs.
Reason for revision
With the enforcement of the Pharmaceutical Affairs Law (November 25, 2014), we have made minor improvements to the description.