Preclinical & Clinical Trial Requirements
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 USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
Under the Pharmaceutical and Medical Device Act (PMD Act), in general, clinical trials for application of marketing authorization approval must be conducted locally. However, data from foreign clinical trials can be used as reference depending on the conditions of such foreign clinical trials.
In the case of additional indications, public knowledge-based applications are allowed, if foreign countries which have harmonized approval systems have approved a product and have substantial usage experience. In this exceptional case, local clinical trials are not required.
2. How are clinical trials funded?
Clinical trials are funded by the company which plans to obtain marketing authorization.
Other than the clinical trial funded by the pharmaceutical company, investigator-initiated clinical trials are allowed, to 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 a preclinical trial protocols, but they must comply with Japan GLP.
Clinical trial protocols must be submitted to the PMDA. Officially an approval is not required, but at the time of submission, the PMDA will review and check the documents.
4. What are the requirements for consent by participants in clinical trials?
The investigator must obtain written consent from participants. Before obtaining the written consent, the investigator has to provide written information to the participant, that must include information specified in GCP rules, including the purpose of the clinical trial, name and access of the investigator, method of 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 for the burden of participation. Also, for the patient participants, other medical expenses related to the clinical trial are paid for 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?
It is an obligation of the sponsor of the clinical trial to compensate medical expenses, medical allowance and compensation. Sponsors must also prepare for such payment, including to get insurance.