Five years ago, the Measures for the Administration of the Registration of Health Foods (Trial Implementation) provoked bursts of waves. Five years later, the first batch of health food approval numbers with a five-year validity period has recently become full. In July this year, the re-registration of these health food products started quietly. Earlier, the State Food and Drug Administration issued a document requesting that all health food products that have been approved for registration but have not been marked with a validity period be fully cleaned and replaced.

In this context, on August 31st, the “Technical Review of Health Food Re-registration Key Points” will further increase the requirements for technical review and other essential elements to solicit opinions from all over the country. Will this be a potential change?

Helps eliminate the disadvantages?

The reporter verified from the website of the State Food and Drug Administration that at present, China has approved 11,275 health food products, including 10,639 domestic health food products and 618 imported health food products. However, the output value of the health industry in China only accounts for 2% of the national GDP. Many, but not perfect, are the top issues faced in the registration and management of the health food industry in China. Comprehensive cleaning up of replacements and health care products that are valid for five years, as approved under the “Regulations on Registration of Health Food Registration (Trial)” implemented on July 1, 2005 Re-registration becomes a top priority.

Five years later, health foods ushered in the first test of the exit mechanism. For products that have not been submitted for re-registration applications and do not meet the re-registration requirements for health foods, SFDA will revoke its approval number. Lin Shuying, director of the Health Products Registration Department of the Guangdong Provincial Food and Drug Administration, told reporters that the re-registration was aimed at 473 products approved after July 2005. The scope involved was relatively narrow and the purpose was to ensure a smooth transition of health product registration management. The entire health care industry does not have much impact. The previous product, clean-up renewal has obvious rectification. "emphasis on source management is to build a big brand." Lin Shuying said.

Yu Fei, a health care product marketing person, told reporters that the state is making efforts in the registration process and is trying to help or dispel the inferior. At present, there are only 200 kinds of health foods on the domestic market, and a large number of products are in the “dormant state”. After the registration renewal, they are either activated or eliminated. What is missing now is not quantity but quality.

In the face of this mid-term exam, the reporter found in the interview that the company seemed to be a bit frustrated. Although business executives such as Chen Junhong, director of Guilin Xiongsen Healthcare Wine Co., Ltd. and Qian Shiliang, general manager of Baituotang Biological Engineering Co., Ltd., all believe that China's health food companies are currently facing tremendous pressure to compete with foreign companies, nurturing core competition. The big brand of force is imperative, but it is worth pondering that when it comes to the impact of the registration management on the company itself, the above-mentioned persons have said that they do everything according to regulations, but words are flashing between them and they are reluctant to say more. The company even hanged up the phone.

Flexible upgrade

It is understood that the current tensions of many companies come from the pressure of policy network tightening. In particular, the technical evaluation points (opinions) emphasize that the types and quantities of raw materials for health foods must not be changed; if the technical requirements for products do not conform to the current regulations, they should be adjusted in accordance with the current regulations. New rules have also been made on the review key points for formulation technology, name technology, labeling and specification technology, functional technology, toxicology technology, quality standard technology, and production technology.
“In terms of policy intentions, registration of health foods will only be stricter and more difficult in the future.” According to relevant figures from the China Health Care Association, there are not many companies concerned about registration, and the deadline is now approaching. Many companies are anxious and some products are currently anxious. Has entered the review stage.

However, what puzzles enterprises is that five years have passed, and the health food technology, production process, and policy environment have undergone tremendous changes. However, the new standard has also reduced the original 27 health care functions to 20 or less. This means that about 780 compressed health food products are facing the re-registration test.

Some business people told reporters that the fate of many health care products is unpredictable. For example, once the product is “renamed”, how will the market cultivated for many years seek the fulcrum for docking? This person believes that, as a result, many products will exit the market.

Of course, there is still flexibility and room for the country to handle non-compliance with existing laws and regulations. “Let's take the example of the company’s rebranding. The new rules allow the original product name to be marked in parentheses after the redefined product name, and use it until the next validity period ends. This gives the company a reasonable transition period.”

Despite this, Qian Shiliang still believes that the approval documents before 2005 will be severely slashed. The next step in the transformation of the company's production workshops in line with the GMP standards will also be a large sum of money. In addition, the "Five-year-one-approval" dynamic management is still at the stage of exploration. Whether or not a dominant enterprise wins is still unknown.

"Before the elimination, we must support it with innovation. R&D and innovation will become the competitive weapon in the future. Increasing investment in research and development of scientific and technological talents and funding is also a major step." Qian Shiliang speaks in the industry.

Strategic guidance

"In fact, registration is only a tactical issue. The core is that China's health care products lack strategic guidance. This is also the biggest weakness and fundamental reason why China's health product product advantages have not been transformed into a market-based market." Yu Fei was interviewed It has been repeatedly emphasized that the registration system is only the source of management and does not solve the problems existing in the subsequent production and management links. How to establish a scientific access system involves more issues at the technical and even social level.
In this regard, Chen Junhong believes that overall, re-registration will increase the company's operating costs, change the original production and business model, which is the inevitable development of the market law. With the advancement of social science and technology and the maturity of the technology market, many products must be re-evaluated, and re-registration is to maintain the continuity of policies and regulations. “The biggest crisis of the enterprise is the absence of a sense of crisis. The era of one-pronged document approval is no longer an issue. The mode of rapid development is also declining. Source checks and corporate self-examination are the keys to adapting to the current market.”

If the registration of health foods is regarded as a means of regulating the market, then the deeper level is the guidance of the health care product strategy. Yu Fei analysis, the current policy should be from the brand marketing, strategic positioning, value innovation in three aspects to make up for companies. For example, at present, melatonin monopolized by scenery is actually the brain gold of the past. Why is there a huge difference in market reaction between the two? It is mainly because the brain gold adopts the development strategy of the city surrounding the countryside, and melatonin counters it. This is the different forces of different strategies in the same product. "At the same time, the state should take measures to strengthen the hard requirements of the health food production enterprises for self-inspection of products and improve the registration threshold so as to ensure the quality of health foods."