Chih-Hwa Wallace Lin

Chih-Hwa Wallace Lin, Senior Researcher, Director, Division of Resource Development, Center for Drug Evaluation (CDE) Tawian, speaks Pharma IQ, about streamlining the clinical trial process and reducing approval time. In this interview he discuss which new guidelines are likely to impact pharma/bio companies in 2011/2012, how the relationship between China and Taiwan will evolve and recommendations for entry into the Taiwanese paharmaceutical market. To watch the full interview go to 

Pharma IQ: Please could you tell us about your current role and responsibilites at the Center for Drug Evaluation (CDE) Taiwan?

Chih-Hwa Wallace Lin: So I am Chih-Hwa Wallace Lin,  Most of my friends call me Wally or refer as Doctor Wallace Lin.  I'm currently the Director for Division of Resource Department.  This is the division in the Center for Drug Evaluation.  And Center for Drug Evaluation is a technical arm which is to support the Taiwan FDA on drug and device technical review.

Currently I do not do any single case review, but rather as a support for the FDA for the policy information, regulation guidance and also to manage the existing resource and future resource more efficiently. 

Pharma IQ: How is the Taiwan FDA currently streamlining regulatory process?

Chih-Hwa Wallace Lin: Currently our FDA is working on both streamlining the current processes and also maintaining the good quality to protect the public health, so that we are putting several new measures.  One for the quality side is we will promote good review practice.  As a matter of fact, Taiwan or Chinese Taipei will host an APEC life science innovation forum, endorse good review practice workshop this coming October.  So this workshop can serve a basic training process for the APEC members, so that's including 27 countries will be involved.  So this is on the quality side.

But as far as the streamlining side of that, since the formation and establishment of Taiwan FDA last years we have done lots of measures to streamline the current process.  One of the examples is on the clinical trial we are putting out similar system to... like CDN systems, so the multinational trials, if this protocol has been approved by US FDA or Europe, like EMA, and if you have this protocol done and clinical trial done in other countries, together, as in Taiwanese site and as long as the protocol is unchanged, un-amended, then that will be a quick approval.  Up to now, since last year, October, the average approval time is less than 15 calendar days.  So this is a very efficient manner I think.  Most of the clinical trials done in Taiwan that are on the similar research will benefit from that.

Last year is the first year of the establishment of Taiwan FDA, so that lots of changes and encouraging improvements here and there, so that in general, last year was a very fruitful year.  However, we do have some new guidance going out.  Biosimilar guidance is being effective and also we approve some biosimilar drugs.  And also in the last year we are not only the streamlining the process, but we are putting measurements together with these kind of efficiency considerations.  So that since last year we also have our risk management plan going out, so that on one side, yes, along with the review line that we will process has been streamlined, but also we have increased the demand for the safety so that, after all, the industry can get the service efficiently, but the general consumer will enjoy the safe and effective products. 

Pharma IQ: What are the most common enquiries your office receives?

Chih-Hwa Wallace Lin: The most common enquiries we often receive is from multinational companies. Usually people are curious about what is the base for our review process. We are an ICH science-based review process and very similar to most advanced countries. 

And secondary, usually people, along the line of the enquiry will ask do we have any particular considerations.  Sometimes we do have some ethical considerations if that particular product is... most likely is a drug.Then we probably will request for some action data and also we discuss with the sponsors. 

And thirdly, usually people will ask, is there any way which can increase or improve the communications among the regulators, industries and the consumers?  We do have a consultation mechanism so that this connotation can be filed online and then we will arrange the sponsor meetings.  And those, we are expecting to have even more friendly service, probably next year, to have a consultation centre set up, so that will increase the communication among the regulators with the industries and also to make the whole process more transparent.

Pharma IQ: Which new guidelines are likely to impact/ be key areas for discussion amongst pharma/bio companies in 2011/2012?

Chih-Hwa Wallace Lin: So about the guidelines, maybe I can also extend this question to a further or wider scope, is that besides guidelines we will also have new measures.  For example, some of the regulations for CPPs, which is a certificate for pharmaceutical products, Taiwan will have a technical review based on no CPP requirement.  I think this will affect the way the multinational companies and also affect the way of people doing the review.  And secondly, we will have our risk management plan, so that... along the line safety and quality can be ensured.  And thirdly, as we will set up more consultation mechanisms, for example, on the medical device side there will have some pre-IDE consultation mechanisms being set up.  

Pharma IQ: How do you think the relationship between China and Taiwan will evolve?

Chih-Hwa Wallace Lin: I think the relationship between China and Taiwan will be better and better.  And based on that, we  already have the collaboration agreement being established since last year, so that the medical products, they will have some negotiation about how the medical products get into China. Of course, at current situations we already have a agreement signed between Taiwan and China since last June.  So that most of the medical products will enjoy this kind of treatment already. 

Pharma IQ: What would be your recommendation for a company looking to enter the Taiwanese market?  

Chih-Hwa Wallace Lin: So as far as our recommendation to companies interested in the entry of the Taiwanese market, I think we work on all the good products which is safe, good quality and with efficacy or effectiveness as far as it is beneficial to our general public. They are all welcome.  So that of course, as regulators, we do have a consultation mechanism so that the company who's interested in the registration and other regulation issues, they are welcome to discuss with us through an application of the consultation. 

Pharma IQ: Which regulators are you working to strengthen your relationships with internationally?

Chih-Hwa Wallace Lin: The regulators on the international levels, we are working very close with the regulators from US FDA, EUs, EMAs and also like Japan's PMDAs and also in Asian area.  Of course, under the framework of APEC we keep a close contact with other agencies, like Singapore's HSA, like Australia's DDAs.  In the international occasions we also met our colleagues from China.

Interview conducted by Andrea Charles.

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