Drug Evaluation Committee 2007-02 Obligation to Report Adverse Reactions to Over-the-Counter Drugs Adjunctively Used in Conjugation (Part 2)
Related classification: Adverse drug reaction reports
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 Pharmaceutical Manufacturers Association of Japan (PMAJ) is of the opinion that it is an appropriate response for a pharmaceutical company to be asked to submit a report on non-serious adverse events caused by concomitant use of an investigational drug. 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 the monitor can be used as general information, there should be no need for a special contract between the sponsor and the investigational site regarding SDV.
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Is it conceivable that such information flow is stipulated in the SOP of the sponsor (or CRO)?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
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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 contract regarding SDV is based on Article 13 of the GCP, which confirms as a contract clause that the medical institution has approved the inspection of source documents.
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Safety information related to clinical trials at the implementing medical institution will be collected by monitors, and the sponsor will take 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 of opinion
With the enforcement of the Pharmaceutical Affairs Act (November 25, 2014), minor changes were made to the description.