Clinical trial packaging gets green light in Asia-Pacific
Clinical trials are fundamental to test the efficacy of a drug prior to mass production or marketing. Previously, many Asian countries were not considered suitable to run clinical trials or evaluations for various reasons, but recent globalisation and regulatory changes have led to greater inclusion of Asia-Pacific countries for the purpose of clinical trials.
An example follows a Japanese pharmaceutical company who chose to conduct its clinical trials outside Japan and selected India as the country of choice for its Phase II clinical trial packaging. Japanese authorities traditionally only approve of clinical data from within Japan for registration, but with changes in regulation, the Pharmaceuticals and Medical Devices Agency (PMDA) now accepts clinical trial data from other Asian countries.
For this Japanese sponsor, having a new compound for clinical development, it was imperative to streamline clinical trial deployment, maximise efficiencies, mitigate risk, and accelerate time-to-market packaging production in this highly competitive environment in order for their complete product to reach shelves.
Fisher Clinical Services in Ahmedabad, India was selected as it is one of the only facilities in the Asia-Pacific region to be fully audited and approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) for clinical trial packaging.
The Free Trade Zone location of Fisher Clinical is a duty-free enclave and usually considered foreign territory for the purposes of trade operations, duties, and tariffs such that:
- no license is required for import/export
- no direct/indirect taxation is imposed (service tax, VAT, Excise/Custom Duty and import/export tax)
- no routine examination by customs officials of cargo
As the facility itself was strategically located, the sponsor was able to store its investigational medicinal product (IMP) before approval and more importantly, without the need for an import license. This would quicken the clinical trial process. Once official approval was granted to the sponsor, the Fisher Clinical Services team initiated packaging immediately. In this, smaller batch sizes were accommodated, either automated or non-automated, allowing the sponsor to also speed up clinical supplies to their target patient base.
With time, the decision of outsourcing to a global player was proven beneficial. The sponsor only needed to communicate with one key contact person in Japan, who would then correspond with the extended Fisher Clinical Services team in Ahmedabad. It was simpler to conduct business in this way as the sponsor could work within the same time zone and the same language. The Japanese contact also had the regulatory expertise needed to facilitate importation of supplies back into Japan and Singapore, and so was streamlined in small batch sizes, making distribution of supplies fairly easy.
It was crucial for the sponsor to ensure Japanese standards were being upheld in the Ahmedabad facility. Fisher Clinical Services was compliant with Japanese good manufacturing practices (jGMP) and Japanese standards, including 100% inspection before, during, and after packaging. Fisher Clinical Services therefore used ‘Virtual Man in Plant’ technology –the sponsor could visit the Ahmedabad facility from Japan and oversee live packaging activities via a secure video link. This enabled the sponsor to ensure standards were being maintained.
The choices were worth it for the Japanese sponsor,and the company intends to follow this approach for future clinical trials, with packaging done in India and distribution afterwards across the Fisher Clinical Services global network. Such action is commendable: Asia-Pacific countries are improving on the requirements of clinical trials from packaging efficiency and distribution, to tax savings, risk management, operational flexibility and finally, global distribution. In comparison to grander portfolios in clinical evaluations, it is an achievement.
