Launching New Drug Products in Asian Markets: Strategies for Reducing Timelines and Costs
As Asia emerges as the largest player in the pharmaceutical market, pharma regulations are fast gaining attention among pharma companies in Asian countries to protect the health and safety of consumers. The ever-changing and increasing scrutiny of regulators across Asia has made it more important for regulatory affairs professionals to keep up to date with the regulatory changes to avoid setbacks that can cost millions of dollars, resources, time and even corporate reputation causing delays in achieving corporate goals and bottom lines! Professor Jack Wong, Director, Regulatory Affairs, Johnson and Johnson Medical, joins Pharma IQ to discuss the current and future Asian regulatory landscape.
Pharma IQ: What changes have you witnessed in the Asian regulatory landscape in recent years?
J Wong: Asia regulations keep on changing, in particular in all the established countries like China and Japan. Another change is that many countries don’t have regulations at the moment but they are going to have new regulations (e.g. drug-medical device combined product) coming, so they will uniquely register in their country very soon. In the past, you didn’t need it. An example of this is India, Hong Kong, Singapore, Malaysia, etc. So there will be two major dynamics that I think companies need to be aware of.
Pharma IQ: What are the key issues that pharmaceutical companies face when managing clinical trials and drug approvals in the Asia Pacific region?
J Wong: In terms of clinical trial and registrations, I think I just mentioned the changes in regulations for established countries and new regulations coming for non-regulated markets, and, of course, nowadays the Asian government/ regulators are learning and changing quickly. So in terms of the future communications and negotiations skills in order to ensure smooth clinical trial and regulatory projects, I think that is something that participants can also get prepared for so that they can have more effective communication with the regulators in Asia.
Pharma IQ: What tactics are pharmaceutical companies utilising to reduce timelines and costs when launching new products in Asian markets?
J Wong: Again, different companies have different approaches but generally speaking the strategy would be mainly focused on two areas: one is on knowledge; one is on networking. What this means is for knowledge they need to really keep track of what’s going on, ie, attending conferences like this. And the second thing is the network - they need to have a strong network with the regulators, the providers, like testing laboratories, even translators, consultants, etc, so that they have a better understanding on how to keep up with the regulations. With this knowledge and network, I believe they can do better registrations which meet the regulatory requirements and hence the approval time will be shortened.
Pharma IQ: What would be one of your top tips for launching a project in a country in that Asia Pacific region?
J Wong: For a product launch in Asia, I think now more and more companies are coming with key steps. Of course, I just mentioned the knowledge and the network of the regulator, which needs to be taken care of. Also, we are aware that many regulatory staff in Asia don’t really understand their product, not to mention understanding their regulations. So many government officials really complain that the regulatory people they deal with don’t understand the products, how they can communicate with the staff and resolve the technical issues there. So I think another typical thing or a key element in terms of success of product launch will be the product knowledge training for the local team as well.
Pharma IQ: What impact do you think the globalisation of the pharmaceutical industry has had on regulations in the Asia Pacific region?
J Wong: Harmonisation organization of pharmaceuticals such as ICH or medical-wise, such as GHTF, I would say both of these organisations have a huge impact in Asia because Asia is still developing their regulations and they take advantage and learn from these organisations. So it’s really important, as Asia regulatory staff, that you should take part or participate in this global harmonisation work so that you can help fine tune the Asian requirements from a top level as well. So that is a very important strategy that companies should be aware of.
Pharma IQ: I understand that you’re going to be presenting at Pharma Regulatory Affairs Asia 2012 which is taking place in Singapore. For anyone interested in attending, what will be your key take home message?
J Wong: I think I would say the conference should able to achieve three things. Number one, they should, of course, have a good understanding of the regulations, requirements, etc. This to me is the knowledge. The second thing is the network which, again, you not only learn something but you meet some regulatory experts from around the world. So I recommend the participants make some good contacts or make some good networks from that. The final thing is that learning how to develop a strategy for future knowledge and network development. This is more important.
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