Lo Phong Mau, director of the Central Bureau of the Medical Party, said in an earlier interview with the media that he is studying the establishment of a drug approval agency similar to the US Food and Drug Administration (FDA), so that Hong Kong can approve drug applications on its own without waiting for foreign licenses in the future. However, today (5th) it was reported that the Hong Kong government has no intention of directly allowing the registration of new drugs developed in Hong Kong or the Mainland, but intends to study changes to the new drug registration system, including drugs only need to be registered in one of the countries listed by the NMPA instead of the current two.

Cui Chunming, president of the Hong Kong Hospital Pharmacists Association, said that if the relevant amendments are true, the most important thing is to see whether Hong Kong has the ability to do the first level of approval, "Hong Kong should do its own check", and relaxation should not be for all drugs, the first step should be cancer drugs, rare disease drugs and critical drugs.

Choi Chun-ming, President of the Hong Kong Hospital Pharmacists Association. (Profile photo / Photo by Gao Zhongming)

At present, the new drug registration system adopts the "second tier of approval", that is, new drugs applying for sale or distribution in Hong Kong must first obtain at least two or more local certificates of pharmaceutical products (CPPs) from the 36 countries or regions included in the reference list, and be reviewed by the Department of Health before applying for registration in Hong Kong.

In a media interview in June, Lo Chong Mau, director of the Central Bureau of the Medical Party, mentioned that he was studying the establishment of a drug approval agency similar to the US Food and Drug Administration (FDA), which would allow Hong Kong to approve drug applications on its own without waiting for foreign approval. However, some newspapers quoted information today that the Hong Kong government has no intention of directly allowing the registration of new drugs developed in Hong Kong or the mainland, but intends to study changes to the new drug registration system, including drugs only need to be registered in one of the countries listed by the NMPA instead of the current two.

Chui Chun-ming, President of the Hong Kong Hospital Pharmacists Association, said on the commercial channel "Departure on a Clear Day" this morning that many cancer drugs or rare disease drugs in the mainland are unable to apply for entry into Hong Kong due to the current drug approval, because other countries may not be willing to approve the relevant drugs, and even if they do, it will take several years. He added that in general, even if the mainland develops drugs together with other countries, it is very difficult to successfully register them in Europe and the United States.

He believes that if the relevant amendments are true, Hong Kong should not directly allow mainland registered new drugs to be registered in Hong Kong like Macao, and the most important thing is to see whether Hong Kong has the ability to do the first level of approval. He agreed that the European and American drug administrations are indeed more rigorous in approving drugs and will look at a lot of data, but Hong Kong's own checkkeeping does not mean that it does not refer to relevant data.

Chui Chunming stressed that there are relevant professionals in Hong Kong, taking vaccines as examples of Fubitai and Sinovac, and medical experts in Hong Kong also look at the relevant data. He estimated that the new measures could lead to more drugs coming to Hong Kong and help reduce them.

The government researches and sets up a drug regulatory agency Cui Junming pointed out that it can attract pharmaceutical companies to Hong Kong for scientific research, and advocate speeding up the implementation of Lo Chuomao said that the proposed drug approval agency does not need to wait for foreign permission Pharmacists are expected to help reduce drug prices, Hong Kong enterprises promote new coronavirus home tests, claim FDA certification is denied The company explained: is applying for [electronic cigarettes] The US FDA allows the sale of IQOS heated cigarettes But it does not mean that the product is harmless to liver cancer, and the new target drug extends the survival period by four months, and the doctor advocates to be included in the drug list as soon as possible