The globalisation and changing regulations of clinical trials has led to the inclusion of many Asia-Pacific countries in the portfolio of target countries for clinical trials today.
Traditionally, only clinical trial data from Japan was accepted by Japanese authorities Pharmaceuticals and Medical Devices Agency (PMDA) for clinical trials for Japanese registration. However, this regulation has recently changed, and the PMDA now accepts clinical trial data from other Asian countries such as Korea, Taiwan, China.
Phase II studies
A Japanese pharmaceutical company chose to conduct its clinical trials outside Japan and selected India as the country of choice for the packaging of its Phase II trial. Fisher Clinical Services was the partner of choice for this sponsor due to its Free Trade Zone location and its compliance with Japanese good manufacturing practices (jGMP) and Japanese standards, including 100% inspection.
Having selected a new compound for clinical development, it was imperative for this sponsor to streamline clinical trial deployment, maximise efficiencies, and mitigate risk, with a view to accelerating time-to-market in this highly competitive environment.
The sponsor noted Fisher Clinical Services, Ahmedabad, was one of the only facilities in the Asia-Pacific fully audited and approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for clinical trial packaging.
Strategically located in a Free Trade Zone, the sponsor was able to store its investigational medicinal product (IMP) at the Fisher Clinical Services Ahmedabad facility before clinical trial approval and without the need for an import license.
Once official approval was granted to the sponsor, the Fisher Clinical Services team was primed to initiate packaging immediately. Furthermore, smaller batch sizes were accommodated, whether automated or non-automated, allowing the sponsor to speed up clinical supplies to the target patient base.
It was important for the sponsor to ensure Japanese standards were being upheld in Ahmedabad. Fisher Clinical Services resolved to find a creative solution to meet this sponsor’s needs.
By using ‘Virtual Man in Plant’ technology, the sponsor could visit Fisher Clinical Services in Japan, to view live packaging activities in Ahmedabad via a secure video link. This enabled the sponsor to ensure standards were being maintained.
The Free Trade Zone is a duty free enclave deemed to be a foreign territory for the purposes of trade operations, duties, and tariffs. It offers additional benefits:
- No license required for import / export
- No direct or indirect taxation (service tax, VAT, Excise / Custom Duty and import / export tax)
- No routine examination by customs officials of export or import cargo
The benefit of outsourcing to a global player was further evident to the sponsor as the project progressed. The sponsor was able to communicate with just one key contact person in Japan. The ability to work in the same time zone and the same language made it easy to conduct business with Fisher Clinical Services. This contact then managed all communication within the extended Fisher Clinical Services network.
The distribution of supplies was seamless to the sponsor. Fisher Clinical Services Ahmedabad worked with colleagues in Japan and Singapore to streamline distribution of supplies in small batch sizes. In addition, this key contact person in Japan had the regulatory expertise that was needed to facilitate importation of supplies back into Japan and into Singapore.
Fisher Clinical Services expertise in shipping large volumes of supplies globally, and in choosing the best courier, lane, and route for all supplies allowed the sponsor to realise cost and performance efficiencies across the supply chain, delivering supplies on-time and in-full to the patient, while mitigating risk.
This Japanese sponsor is planning to follow this seamless, proven approach for future trials, packaging in India and distribution across the Fisher Clinical Services global network.