A Brighter Future for Regulatory Professionals

Regulatory Focus (RF) Interviews Bird Shi, Regional Regulatory Affairs Director, Abbott Nutrition, Greater China.

After a career as a researcher at the Institute of Nutrition and Food Safety, Chinese Centre for Disease Control and Prevention (China CDC), Bird Shi became a regulatory affairs director at one of the world's top 500 enterprises. She has witnessed how the regulatory system of China's food industry has improved since its founding and although regulatory affairs in the industry presents many uncertainties, Shi, a firm believer of the coexistence of challenges and opportunities, is optimistic about the career prospects for the regulatory affairs specialists in the food industry. Hear what she has to say in this candid interview.

BS—I am still a researcher at heart. I was hoping to do research at the Institute for my whole life. I was in charge of studying the food composition database to make a general nutrient analysis of the daily food materials collecting basic data for national nutritional monitoring. Other countries were doing great in this area, while China was applying only limited resources into research pertaining areas, such as food safety and toxicology, so our national investment in nutritional research was reduced. Also, China had many varieties of food and required a large amount of funding for food database analysis. The shortage of research funds was problematic. As researchers, we often felt we were not valued and there was little respect for our abilities. When my career development reached an impasse, I discovered Abbot was recruiting regulatory affairs professionals and I thought making such a move might offer a new, important juncture in my career. So, I took advantage of the opportunity and joined the company.

RF—As a regulatory affairs specialist with a technical background, what benefit does this bring to your current work?

BS—I have always believed that, no matter whether you are engaged in registration or regulatory affairs, you must have a technical background. Since regulatory affairs touch on many technical related rules and policies, without a technical background, individuals would find it difficult to understand the relevant regulations and the meanings behind them. Without that knowledge, you could not do the registration, let alone influence the regulations. Second, whether reviewing institutions or scientists, you cannot talk on the same level of those you are reviewing if you lack a technical background. Third, a technical background helps you to think about issues from a strategic perspective. People with a science and engineering background demonstrate strong logical thinking that comes with a technical background.

RF—What role do regulatory affairs professionals play in the business of food industry? Do they have room further development?
BS—In the food industry, regulatory affairs professionals are critical business partners. There are a lot of uncertainties in the regulation of the food industry and how the corporate business model is closely linked to national regulations. For example, advertising and other key decision issues require the participation of regulatory affairs specialists. For the corporate core R&D, regulatory affairs professionals also can offer numerous forward-looking suggestions and advice as to which direction development can go forward.  So, regulatory affairs professionals are an integral part of the food industry when it comes to making strategic decisions.

Regulatory affairs specialists in industry require a lot more guidance because for many people, including some of the regulatory affairs specialists have the impression the regulatory affairs department is just a supportive department for registration. They do not realize regulatory affairs professionals have strong technical backgrounds, a detailed understanding of the products, outstanding communication skills and strategic thinking ability with great potential and many possibilities in their career development. Their skills are transferable to many business functions such as marketing, sales, R&D and government affairs.

However, as the regulatory affairs team is generally very small in a company, they are often neglected and get little professional guidance, planning experience or training. Because of this, many regulatory affairs professionals have no idea they can have broader development in industry although they have been engaged in regulatory affairs for many years. I have no doubt regulatory affairs professionals are an underestimated group.

RF—When compared to the drug industry, what is the nature of the food industry's regulatory supervision? Under the current regulatory framework, what is the biggest challenge facing regulatory affairs specialists in the food industry?

BS—Whether in China or elsewhere, the regulatory system overseeing the drug industry is no doubt sounder than for the food industry. First, the drug industry has a very mature and regulated process before drugs can gain their approval and are released to post-marketing supervision. Also, standardization of the drug industry is very high; thus the registration materials of some drugs in the developed countries may be directly applied in China. Third, the personnel in the global drug industry are more technically qualified and professionally trained, whether they work in the supervisory institutions or in industry.

By comparison, the food industry is behind the drug industry in terms of training and skills. It is still in the developing stage. For example, the Sanlu milk powder scandal caused serious damage to the image and reputation of the food industry in China, leaving no one willing to buy Chinese exported food materials; consequently the whole food export trade suffered heavy losses. In addition, some media reports put labels of food safety on some incidents that had nothing to do with food safety, causing a negative impact as well. China has subsequently attached more importance to food safety. Since the release of its first Food Safety Law in 2009, China has, over the last six years, become increasingly strict in the supervision of food safety, bringing about a remarkable improvement in the food regulatory system, the supervision of food enterprises and the qualities of regulatory agency personnel. However, due to the large number of food enterprises and the wide variety of food types, there is still an uphill journey for the food industry.

From the perspective of the personnel qualities, regulatory affairs professionals in the food industry have been continuously improving. Compared to the personnel engaged in the registration of medical devices in drug industry, food regulatory affairs professionals are required to be more creative because the food regulatory system is still under construction. The government welcomes those with a strong technical backgrounds and expertise to participate in developing regulations, so food regulatory affairs professionals are more forward-looking and can assist the government building a more scientific and reasonable regulatory standards system.

From the perspective of the regulatory agency, no matter whether it is before or after the release of a drug, and no matter whether they are imported or produced in China, supervision of drugs is under the supervision of the China Food and Drug Administration (CFDA), so the regulatory structure is very clear. But, as for the food industry, it adopts a segment-management model where imported food is supervised by General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (AQSIQ), and food produced in China by CFDA while food materials are under the Ministry of Agriculture of the People's Republic of China. The whole industry chain is segmented and involves many regulators, resulting in often ineffective communication between the regulators, which produces great difficulties for our work.

RF—China implemented the new Food Safety Law on October 2015. What impact will it have on regulatory affairs professionals?

BS—There are many changes in the new law and many regulations remain to be improved further. Yet, everything is certainly developing in a better direction. For regulatory affairs professionals in the food industry, both challenges and opportunities exist. On one hand, as the requirements for food enterprises expand, there also will be an increasing number of people becoming regulatory affairs specialists in the industry to better ensure compliance performance, which is favorable for us. This leaves no doubt industry employment is promising.  On the other hand, there are also more regulations. Ensuring every regulation is followed, while also seeking to exploit the corporate advantages to the maximum, is indeed a challenge. With the launch of the Food Safety Law, many supporting regulations will be published and bring with the new regulatory environment uncertainties requiring us keeping a closer eye on the regulatory changes and adjusting the corporate direction as necessary.

RF—There is a recognized problem with the indiscriminate use and abuse of food additives in China. Many sellers hype the positive function and role of food additives, but no one talks about the negatives, so the general public it is uninformed. The new Food Safety Law stipulates the State has implemented a licensing system for food additives production. According to law, any organization or individual with production equipment or facilities, professional technicians and management system corresponding to the food additives varieties it produces, must obtain a food additives production license. How do you interpret the stipulation of the new Food Safety Law as to food additives?

BS—There have been strict regulations on food additives since the 2009 Food Safety Law, and all of the food additives producers have been required to implement registration system since 2009. First, you must obtain a production license. Second, food additives can be allowed to be put into the food only after approval by the Ministry of Health. Third, the State has made various quality safety standards for each food additive and specific regulations on quality and specifications. So, the new Food Safety Law is actually an extension of the regulations in the 2009 Food Safety Law.

The general public's misunderstanding of food additives is, to a great extent, caused by false information disseminated through the media. Food additives are indispensable to the food industry, and it is no exaggeration to suggest the modern food industry cannot go on without food additives. Food additives are widely used across the world, but what matters is their dosage. Some of the food additives used in China are examined and approved by the Codex Alimentarius Commission of such international organizations as the World Health Organization, and also universally used. China needs to strengthen the self-discipline of food enterprises to work strictly within the standards and also strengthen the supervision and law enforcement of governmental departments. Finally, public guidance needs to improve so as to correctly lead the consumers to recognize the role and safety of food additives.

Bird Shi began her employment with Abbott Nutrition in 2002 as senior regulatory specialist and was promoted to director of regulatory affairs in 2011. She is primarily engaged in food additive registration, novel food registration, drug registration, national standard and regulation influencing, regulatory landscape shaping, crisis handling, government relationship development, RA talent acquisition and development. Before joining Abbott, Shi worked at the Institute of Nutrition and Food Safety, China CDC for more than seven years, mainly in nutrition and food composition research. She obtained bachelor's degree from Beijing Agriculture University for Food Science and Nutrition in 1995, and in 2001, received her master's degree from Peking Medical University for Epidemiology and Statistics. Shi can be contacted at [email protected].