Not only does China have great market potential and is fast becoming a manufacturing powerhouse for the global Pharma industry, but it is also being recognised as the future epicentre of Research & Development. The drug discovering capabilities of China are largely more desirable when considering its already obvious advantages in cost. Conducting R&D in China can save research costs up to 60% and drug developers can expect typical savings of 30% compared to Western costs.
So as you can see, Asia is fast becoming an international hub for Clinical Trials. China, India, Korea and South East Asia are all key regions for development. Most big Pharmaceutical companies have now expanded into Asia, taking advantage of the cheaper labour costs and rapidly expanding market intelligence. However, these benefits can come hand in hand with some complications; the regulations for importing and exporting out of Asia, particularly China are considerably more complex than elsewhere.
Presently there is a significantly longer process involved for granting import/export approval for drugs in China than there is elsewhere in the world. Even within Asia, China has by far the longest processes. The Biotech industry is still very new to China and the Chinese Government. Although progressing at a rapid pace, processes are still being designed and optimised. Some applications still require ‘hand by hand’ operation and cannot be completed online.
The average time it takes to gain regulatory approval for a Clinical Trial in China is nine months.
What about other countries in Asia?
Korea (closely followed by Singapore) is the most developed country in Asia in terms of Pharmaceuticals and regulatory processes. Here the average time for granting regulatory approval for a Clinical Trial is just 30 working days. In Singapore, it takes roughly a month for regulatory approval, but it takes a further month to obtain approval from the EC (Ethics Committee). Whereas in Hong Kong these processes can run at the same time, thus reducing approval time for both to an average of nine weeks. Then a licence to import a Clinical Trial must be granted, which usually takes two weeks.
The above goes some way to illustrate how difficult it is to set up a Clinical Trial in China. However, Clinical Trial Logistics can be tricky wherever they take place. Below is a simplified example of the steps that a Specialist Logistics Courier would take when organising a Clinical Trial movement from various European destinations and delivering them to a research laboratory in China:
Moving a Clinical Trial to and around Asia - an example
We will start at the beginning:
Pharma Co. are conducting a Clinical Trial in clinics across Germany, Switzerland, Belgium and Poland. They need to move the various samples collected to its research laboratories in Shanghai, China.
Pharma Co. would go to a Specialist Courier like ABC123 Courier and request a quote.
Pharma Co. can quote for an individual shipment within the trial, or can quote for the movement of the entire Clinical Trial.
This will include multiple collection points and consignees across the globe.
In this instance, Pharma Co. would like ABC123 Courier to organise the movement of the entire trial.
For ABC123 Courier to provide a quote, they need to be able to classify the product(s) being shipped.
If Pharma Co. provides a detailed description, then the courier can classify the product more quickly.
If a description is not provided then ABC123 Courier must research the product on behalf of Pharma Co. in order to classify it correctly.
The time involved in this process is dependent on the complexity of the product.
Once the product is classified, ABC123 Courier will suggest and provide appropriate packaging so that the product arrives at Pharma Co.’s Research Laboratory in Shanghai, in perfect condition.
For example, some products need to be shipped in a temperature controlled environment.
ABC123 Courier must now design a route for the shipments that ensures they meet their required delivery schedule, as outlined by Pharma Co..
ABC123 Courier must now go back to Pharma Co. with the proposed routing, packaging and classification to receive authorisation on the shipments.
Pharma Co. can track the shipments with ABC123 Courier’s Track & Trace facility on their website.
Once the shipments have arrived at Shanghai Airport, it will go through Customs and providing the product(s) has been classified accurately and all permits are in place, there will be no delays.
ABC123 Courier’s Chinese transport unit will pick the shipments up and take them to their final destination.
ABC123 Courier and Pharma Co. will both receive confirmation that the shipments has arrived.
This process seems simple enough when broken down as above, but various timelines have not yet been considered.
Regulatory approval has to be obtained and we’ve already discussed how this can be a lengthy process. As explained above, gaining regulatory approval for importing samples to Asia is a longer process than most continents, but China can be particularly difficult. This can be for many reasons, including:
- The fact that the industry is still relatively new to China
- Their stringent import and export rules
- The amount of regulatory bodies to gain approval from
With so many bodies to gain approval from, there are far more opportunities for delays to occur – and this is something that Pharma companies need to be aware of and factor in when involving China in a Clinical Trial. For example, when choosing a Specialist Courier, it is wise to consider more than the price. A good Specialist Courier will have an in-depth knowledge and thorough understanding of all local Regulatory Bodies and their requirements. Thus ensuring the process is as swift and efficient as possible.
As mentioned above, this process takes varying amounts of time in different countries in Asia. For example, both Korea and Singapore have a relatively quick regulatory processes and are able to deliver Clinical Trial approval within 30 working days.