Norman Ng, Director of Patient Advocacy and Public Affairs at Healthcare Thinkers, shared a post on LinkedIn:
“Title: New Chapter of the Year of the Horse: Enhancing the New Drug Registration Mechanism to Enable Hong Kong Patients to Use Life-Saving Drugs as Soon as Possible
Good morning, everyone! Ben and Norman are here again, good medicine is used. Last time, we talked about how to introduce innovative drugs to Hong Kong, and there is an office for introducing new drugs. Ben, we keep saying “in, in”, but what if the approval and registration are lagging behind?
It seems that something came out yesterday, and an article like this came out, and the first thing to do is to register. Therefore, this title is very eye-catching: “There is a gap in the 1+” mechanism of new drugs. We in Hong Kong must take the lead, and as we enter the Year of the Horse, we must take the lead!
The article mentioned that the current registration fee only costs 1,100 yuan, compared with other international drug regulatory agencies, the cost is really far different.
If the existing charging mechanism is used, it will be difficult to introduce new drugs. Because after all, if you want to look at the original data, you need to have human resources and specialization, all of which require financial resources. So how can you find some, not to mention self-financing, at least if you can maintain and continue to develop, the source of your financial resources needs to consider how to open source, sustainability is very important.
Especially now new drugs, it is not just an indication. Let’s not talk about those GMP/PICs, new drugs are coming, and now they are very powerful, a drug has 10 indications, and there will always be a gradual increase. A new drug has new indications that will be added over time; In addition to new indications, there may also be changes such as its validity period, which actually need to be approved.
So if you draw a fee, or if you don’t charge for these minor changes, it’s actually not that healthy. So I think that in the future, CMPR can accelerate the processing of some new indications, or some new changes, and extend its validity period. In these cases, they should actually “charge on an itemized basis” so that they can handle it with more manpower, so as to speed up the approval process.
Especially new indications, mainly new innovative drugs, it needs to add new indications. If you are slow, the introduction of public health institutions will be slow, and the opportunity for the general public to receive subsidies will be longer, which will affect the public and patients.
So we really want to congratulate the new office: one is the office for introducing new drugs, and the other is the registered CMPR, both of which are successful!
Congratulations on your good health, OK, everyone says, see you after the New Year!”
Other articles featuring Norman Ng on OncoDaily.