Preclinical & Clinical Trial Requirements
Nishimura & Asahi / Japan
The low-down on the situation regarding preclinical & clinical trial requirements in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
Generally, under the PMD Act, clinical trials relating to applications for marketing authorization approval must be conducted locally. However, data from foreign clinical trials can be used as a reference, depending on the conditions of those foreign clinical trials.
In case of additional indications, public knowledge-based applications are allowed, if foreign countries that have a harmonized approval system have approved a product and have substantial experience with its use. In this exceptional case, local clinical trials are not required.
2. How are clinical trials funded?
Clinical trials are funded by the company that plans to obtain the marketing authorization.
In addition to clinical trials funded by pharmaceutical companies, investigator-initiated clinical trials are allowed, for which research grants are often provided by national centers.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
There is no official requirement for preclinical trial protocols, but they have to comply with Japan GLP.
Clinical trial protocols must be submitted to the PMDA. Official approval is not required, but the PMDA will review and check the documents at the time of submission.
4. What are the requirements for consent by participants in clinical trials?
The investigator must obtain written consent from the participants. Before obtaining the written consent, the investigator has to provide written information to the participants, which must include information specified in the GCP rules, including the purpose of the clinical trial, the name and access information of the investigator, methods used in the clinical trial, possible adverse events, and trial compensation.
5. May participants in clinical trials be compensated?
Yes. The participants are paid a reasonable amount to compensate them for the burden of participation. Also, for patient participants, other medical expenses related to the clinical trial are paid by the sponsor.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
The sponsor of the clinical trial is obligated to compensate participants for medical expenses, and to provide a medical allowance and compensation, and also has to prepare for such payments, including obtaining insurance.
