Registration of chemical drugs is difficult, three types of drugs c

There is a class of drugs that have been standing in a bad position. This is the application of generic drugs from overseas manufacturers in mainland China. Before yesterday, these drugs were also called "new drugs." Now its status has fallen to "generic drugs." Without change, its registration classification is still three categories. For the sake of simplicity, it is temporarily called the "primary three."

The CFDA issued an announcement on the release of the work plan for the reform of the registration of chemical registration [No. 51 of 2016 (hereinafter referred to as No. 51 document)]. The definition of the new drug was instantaneously upgraded from "New China" to "Global New". The entire chemical registration was completed. The situation has undergone major changes, and the fate of the "Primary III" has been greatly affected.

As the name changed, the status and treatment of the “Little Three” changed.

No longer have a new certificate for new drugs. I am afraid that the transfer of technology after the listing is not possible. Of course, the new path is a listed licensor;

Since then, it can only be a generic drug, and it can no longer use a trade name;

No 3-4 year testing period;

Clinical test approvals may not be transferred.

The policy has changed. What is the difference between the old and new "primary three"?

Circular No. 51 stipulates that applications for registration of chemical drugs that have already been accepted may continue to be reviewed and approved according to the original regulations, or they may apply for review, approval and approval in accordance with the new registration classification.

The original regulation: Clinical trials are PK+100 confirmatory clinical trials.

New rule: BE+ conducts clinical trials according to internationally accepted technical requirements

So far no one can answer what is "according to international prevailing technical requirements for conducting clinical trials". As for confirmatory clinical trials, some people say that it is purely based on management considerations. Dare to think that the drugs to be compared in confirmatory clinical trials should be drugs that are marketed in China. Now these drugs are all drugs whose efficacy is questioned and the consistency of quality and efficacy needs to be evaluated. Is there such a confirmatory clinical trial? Can you stand it?

Since the “Primary 3” applications that have been accepted have established green channels in accordance with the new registration classification for review and approval, and accelerated the review and approval, the standards will only be higher. As a result, oral preparations do not have the clinical luxury of BE and injections, but I am afraid that they will not require complete large clinical trials because the definition of “primary” is to have complete and sufficient safety and effectiveness. Sex data is used as a basis for listing drugs. In this analysis, the new rule is to increase the technical requirements for confirmatory clinical trials, such as increasing the number of cases.

In view of this, for the three types of products that have already been registered, especially for obtaining clinical approvals, perhaps waiting for the review and approval of the original provisions can better grasp the listing opportunities in the coming years.

The monitoring period is gone. What choices should be faced by prospective “primarily juniors”?

Circular No. 51 lowered the “primary” from new drugs to generic drugs and cancelled the monitoring period. Has the remaining monitoring period of the monitoring period been still valid?

The monitoring period for the “Primary III” comes from the current “Administrative Measures for Drug Registration”. In the last sentence of the No. 51 document “Administrative Measures for Registration of Drugs” that is inconsistent with this plan, it is implemented according to the requirements of this plan. In this way, "this plan" is equivalent to "existing" the remaining monitoring period of the existing listing. Of course, this is speculation and it is subject to the authoritative interpretation of the CFDA.

The original varieties that cannot be used for imitation can be submitted to imitation, and the time for a small number of “primary threes” to divide the market will be shortened.

Whether the clinical approval in the hand is based on the original provisions of clinical trials or four types of imitations (the original six types of imitation) is confusing, and there are many variables in the time to market and development costs.

In the course of clinical trials, prospective “primarily juniors” are faced with the risk of clinical trials being standardized and demanding improvement. To do clinical trials according to the original regulations or to report four types of imitations (original six types of imitations) must not be entangled.

If we really don’t have a monitoring period, wouldn’t it be a big deal to grab the first person? Especially for injections, we all hold clinical approvals, watch you spend hundreds of millions to do clinical treatment, and then grant me direct batch production, not only saving Money also circumvents the risk of clinical trials being abandoned. All think so, if the original research is not imported, how can the three types of drugs be listed? This seems a bit messy.

In a word, the influence of No. 51 article on the development of three types of chemical drugs is huge. Pharmaceutical companies need to adjust their development strategies. Of course, the abrupt changes in policies also create some exclusive varieties and become the beneficiaries of the policy. Some policy rules are still to be clarified, especially how the new three types of clinical trials will be required and how the original regulations and new programs will be implemented.

It can be said that with the publication of the No. 51 document, the “Little Three” who has made great contributions to the Chinese pharmaceutical industry has begun to enter a new stage of re-finding its own positioning. Although it has lost the aura of new drugs, it has complete and full security. Effectiveness data As a basis for listing, the generic product of the original research drug will increase its gold content. We have reason to believe that the “Primary 3” born according to the new standard will make greater contributions to protecting the health of the Chinese people.