Q9: What is the difficulty for imported OTC products entering the China pharma market? Will the new “technical guidelines and procedures for OTC marketing and registration” mentioned in the new “Provisions” provide a better suited market entry for the registration of OTC?
A: Under the current background of the classification of chemical drugs, it’s unlikely for overseas OTC products to obtain approval from NMPA successfully. The main reason is that OTC is neither a category of innovative drugs, nor can it be applied strictly according to the concept of generic drugs. As there’s no definite original product, it’s difficult to develop OTC products according to the conceptual framework of general generic drugs.
Q10: What is significance of the implementation of the communication meeting policy for applicants?
A: The implementation of communication meeting policy is originated from “NMPA Announcement on Issuing Administration Law of Drug Development and Technical Review Communication” (No.74, 2018). This announcement stipulated that it is applicable to initiate the communication meeting relating to innovative drugs, improved new drugs, biosimilars, complex generic drugs and consistency evaluation products in the process of development and registration application. Generally, applicants will propose actively to apply for communication meeting. The main issues of application product could be solved previously by the CDE meeting or written letter, phone response from CDE, in order to accelerate the process of market approval.
Q11: What is “Catalogue of Chemical Drugs” and its value?
A: “Catalogue of Chemical Drugs” is also named as “Catalogue of China Marketed Drugs”, which is issued on Dec 29th, 2017. The catalogue has recorded the drugs with safety, efficacy and controllable quality, and confirmed RLD and RS (is short for Reference Standard). Similar to the Orange Book of FDA and PMDA, “Catalogue of Chemical Drugs” provides a good reference for the ongoing consistency evaluation work of chemical drugs in China.
Q12: What is the difference between the current trial of No.80 and “The applicant submits an application for approval of drug as Marketing Authorization Holder (MAH) after completing studies on pharmacy, pharmacotoxicology and clinical trials to support drug approval, confirming specifications, completing production process validation of commercial scale, and preparing to undergo drug registration inspection and testing, the applicant shall apply for market approval” mentioned in the new “Provisions”? Are there any new requirements in the new “Provisions”?
A: The implementation of this clause is clearly inconsistent with the specific requirements in current trial No.80 promulgated in May 2016 namely, “Requirements for application materials of chemical drugs’ new registration classification”. The chapter of process validation and evaluation of 3.2.P.3.5 in No.80 has mentioned that for non-sterile process procedure, applicant could submit the process validation report (No:_ , Version: ), or the process validation protocol (No: , Version: _) and commitment contract of the first three commercial production batches’ validation after marketing. As the conflicted situation, the No.80 might need to be subject to the current new “Provisions”.
Q13: How to understand the Article 35 of generic drugs, in vitro diagnostic reagents in accordance with drug management and other eligible conditions in “Provisions” that “The applicant can apply for drug market approval directly, after the evaluation by the applicant, and deems it unnecessary or impossible to conduct a clinical trial and conforms to the conditions of clinical trial exemption. The technical guidelines and relevant requirements of clinical trial exemptions are formulated and issued by the Center for Drug Evaluation (CDE)”? And how to understand and implement this in actual projects?
A: Currently this article has not been implemented yet. According to the article, the applicant could apply directly for market approval, after evaluating there’s no need to conduct clinical trial. Based on this, many imported injection of class 5.2 could apply for market approval directly from July 1st .2020.
However, the current actual situation is class 3 and 4 of chemical drugs can apply for production directly. As for imported class 5 chemical drugs, there are mainly two situations which can apply for market approval directly: (1) the class 5.2 oral solid preparations have completed BE study or have the BE study approved overseas can apply, (2) rare diseases and other conditions can apply for market approval directly. The process of clinical application firstly and then market approval is still work for other products.
Q14: How to understand the term “based on risks” that has been mentioned many times in the new “Provisions”?
A: “Based on risks” is frequency mentioned both in regulations and laws and the communications with CDE in these two years, which makes the review and approval more flexible than before. In the past, whether high risk products like class 5.1 injection or super low risk products like pharmaceutical excipients in topic use preparations will be issued a “Registration Inspection Notice”. Understandably, this causes a heavy burden on the resources of the national inspection center. The “Provisions” has further consolidated the industry reform of theses years, and is still being improved continuously.
Q15: What are the highlights of the registration inspection link in the new “Provisions”?
A: The biggest highlight is the applicant can decide to whether to apply for registration inspection in advance based on its product according to relevant clauses. If the product has a high risk, the possibility of registration inspection is very high. The applicant may propose the application in advance in order to ensure the registration inspection could be completed in time successfully.
Q16: What is the purpose and significance of adding chapter “Accelerated Drug Market Registration Procedure” in the new “Provisions”?
A: The “Chapter 4, Accelerated Drug Market Registration Procedure” has established four accelerated channels for breakthrough therapeutic drug procedure, approval procedure with condition, priority review&approval procedure and special review&approval procedure. Among them, breakthrough therapeutic drug procedure and approval procedure with condition are mainly for products in clinical trial phases. Priority review&approval procedure is applicable for products in market approval step. NMPA can decide to conduct special review&approval for drugs required for public health emergency, in the event of a threat from a public health emergency or after a public health emergency occurs in accordance with law.
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This article is originally translated from Canny.
RLD Reference Listed Drug
RS Reference Standard