Food and drug regulatory filing and its application of the law.

Original title: Food and drug regulatory filing and its application of the law
With the deepening of the reform of the administrative examination and approval system of food and drug supervision, the government functions have been further transformed, the food and drug regulatory department has cancelled and decentralized a number of administrative examination and approval matters, and deepened the reform of food and drug supervision gradually from the relaxation of market access to the strengthening of after-the-fact supervision. Administrative filing, as a relatively "flexible" mode of supervision, is increasingly used in food and drug supervision work, which respects the independent participation of administrative relatives to the maximum extent, and also reflects the administrative principle of efficient and easy people, and can achieve the goal of adjusting the function of food and drug supervision. At present, there are still differences between the food and drug regulatory departments in understanding and applying the law, and there are still many aspects of the administrative filing system that need to be perfected.
concept of administrative filing and its classification
The concept of administrative filing
according to the interpretation of the Xinhua Dictionary, "filing" is to point to the competent authorities to make a written report for examination. According to this interpretation, the core connotation of the filing refers to the parties reporting to the competent authorities, which accept their reports and keep the relevant information for public release. In other words, filing is a factual act, and the outcome of filing does not have any direct legal effect on the matter that needs to be filed. In practice, the filing is widely used and has far exceeded the meaning of the legal level itself, most laws, regulations and regulations do not directly explain the concept of filing, but the filing as an administrative act that is widely applicable and more arbitrary.
The filing in German administrative law refers to a way in which the parties must fulfil their obligation to inform the administrative organ and the necessary procedural law obligations in the exercise of their rights, the purpose of which is to make the administrative organ aware of the activities that the citizen intends to engage in that may affect the public interest, so as to take timely preventive measures. Article 37 of Chapter V of Japan's Administrative Procedure Law provides for a filing system and defines it as "the act of notifying the Office of Administration of certain matters (except for acts that are an application), which is a direct obligation under the Act (including the obligation to have a certain legal effect as it is expected) Notice act), for the filing with the formal requirements stipulated in the decree, when the filing arrives at the office of the submitting organ as stipulated in the decree, the filing person has fulfilled the procedural obligations to be fulfilled", the legislative purpose of which is to avoid the filing playing the same role as the administrative license in the implementation process. South Korea's Administrative Procedure Law refers to the filing as a "declaration", and article 40, paragraph 1, stipulates that "when the administrative organ in charge of the declaration of the declaration of the obligation to end certain matters is notified to the administrative organ, the administrative organ in charge of the declaration shall reveal the information and the receiving organ required for the declaration, and declare the required matters in accordance with other decrees and other provisions, or prepare these notes for all to read", and stipulates the specific procedures for the declaration in the second, third and fourth paragraphs.
, the extension and meaning of administrative filing are more, and they are not the same in different administrative fields. There are higher-level departments to lower-level regulations, normative documents for the type of legislative review of the record, but also the higher administrative organs for the lower-level administrative acts of administrative law enforcement review of the record. Unlike the extension of the above-mentioned filing, the filing of food and drug supervision refers only to the filing of a declaration by an administrative relative to the food and drug regulatory department in accordance with the provisions in the production and operation activities of food and drug.
Similarly, Article 2 of the Measures for the Administration of Administrative Filing in Guangzhou City (Guangzhou Municipal People's Government Order No. 50), which has been in force since March 1, 2011, defines administrative filing as "the act by which an administrative organ, in order to strengthen administrative supervision and management, requires citizens, legal persons and other organizations to submit relevant materials for their specific activities in accordance with the law, and to file the materials for examination". The definition of the connotation of administrative filing in the above-mentioned regulations is basically in line with the current practice of administrative departments for filing.
a long time, food and drug regulations and other laws and regulations, although many provisions are provided for the record, but these laws, regulations by-laws or other subsequent administrative interpretations are not specifically stated. Article 3 of Article 3 of the Measures for the Administration of Medical Device Registration (State Food and Drug Administration Order No. 4), which was implemented on October 1, 2014, clearly defines the filing of medical devices for the first time: "The medical device filer shall submit the filing information to the Food and Drug Administration, and the Food and Drug Administration shall file the filing data for examination." Article 3, paragraph 2, of the Measures for the Registration and Filing of Health Food (State Food and Drug Administration Order No. 22), which has been in force since July 1, 2016, defines the filing of health food: "Health food filing refers to the process by which health food production enterprises submit materials indicating product safety, health function and quality control to the Food and Drug Administration for archiving, disclosure and preparation in accordance with legal procedures, conditions and requirements".
Every reference to the concept of medical devices, health food filing, the concept of food and drug regulatory filing can be defined as, "food and drug production and operation enterprises in accordance with the legal procedures, conditions and requirements, the relevant materials engaged in production and operation to the food and drug regulatory departments for archiving, disclosure, preparation of the act."
The nature of administrative filing
Because the concept of "filing" is not uniformly defined in the legal profession, in administrative practice, the relevant personnel have different views on the nature of the record, the more common views are mainly as follows:
First, the first view is that the filing is an administrative license in a broad sense, the administrative license in the broad sense includes licensing, recognition, registration, certification, approval, inspection, approval, audit, declaration, filing, including all acts. After some administrative examination and approval matters have been cancelled and changed to the record, the pre-examination procedure similar to administrative license is still set up in the implementation, and if the administrative relative does not pass the record, this is the case. In fact, the promulgation and implementation of the Administrative Licensing Law has made a legal distinction between administrative licensing and filing. Moreover, as an act of administrative fact, the content requirements of the record generally come from the clear provisions of the regulations, but the administrative organ's record or knowledge of the relative person's situation will not produce the effect of empowerment in the sense of administrative law, in essence, the record should not affect the administrative relative to start to engage in corresponding activities. Therefore, there should be a clear distinction between filing and licensing as an administrative legal act, but due to the lack of system design, such as concept and procedure, the two should be confused with each other in their implementation.
second view, filing is an administrative confirmation. Some filing provisions do not set rights and obligations on administrative relatives, but only to determine the existence of administrative relatives, so that administrative organs to statistical summary or facilitate public inquiries, so there is a view that the Medical Device Supervision and Administration Regulations, Medical Devices Management and Management Measures, Medical Devices Business Quality Management Code, the operation of the second category of medical devices enterprises for the record is administrative confirmation, on the grounds that the regulatory documents on the operation of enterprise personnel, equipment, sites, systems and so on have put forward specific requirements. However, the independent form of administrative confirmation refers to the administrative subject in accordance with the law to the administrative relative's legal status, legal relations or related legal facts to identify, identify, prove and declare the specific administrative acts. Administrative confirmation, generally through the investigation or testing of the steps between the parties to the ownership dispute or legal facts are not clear, so as to end the state of uncertainty. After the filer reports the materials to the administrative organ, the administrative organ often does not do substantive examination, but records and discloses the objective facts. In this sense, the behavior of the second category of medical device filing should be different from the administrative confirmation in the sense of administrative law.
third view, filing is a kind of supervision behavior, which includes both the supervision of filing legislation and the supervision of the administrative act of lower administrative organs. This kind of filing mainly exists between the legislature and the administrative organs or the administrative organs at lower levels, does not involve the administrative opposite person, and the meaning of the administrative record discussed in this paper is not completely consistent.
fourth view, filing is informing behavior. The act of notification generally refers to the administrative relative engaged in related activities, the need to inform the competent authorities of the corresponding situation, in order to facilitate the supervision and inspection of the competent authorities afterwards. This act of providing information does not affect the administrative relative to engage in specific production and business activities, so it is different from the administrative license with the nature of pre-licensing. The act of informing is basically in line with the meaning of administrative filing, and this paper generally agrees with this view. At the same time, the act of informing is mostly from the perspective of administrative relatives to consider the problem, if from the perspective of administrative organs, the record as an act of administrative facts, but also should be informed of the content, procedures and relief and other aspects of a relatively complete system norms.
the classification of administrative
, one is external administrative filing and internal administrative filing. According to the subject and content of the application for filing, administrative filing can be divided into external administrative filing and internal administrative filing. External administrative filing refers to the act of citizens, legal persons and other organizations providing relevant materials to administrative organs in accordance with the law, and administrative organs archiving such materials for supervision after formal examination in accordance with legal procedures. For matters requiring regulation but not strict prior review of the approval process, filing can be effective in facilitating ex post facto supervision. Internal administrative filing refers to the administrative organ that makes administrative acts or formulates regulations and normative documents, and reports the legal documents or the information of making regulations and normative documents to the administrative organs at the higher levels in order to realize the administrative effect of supervision and restriction at the higher and lower levels of administrative organs. Internal administrative filing, generally must have clear regulations, in strict accordance with the statutory procedures and time limit requirements to complete.
is mandatory filing and arbitrary filing. This classification is mainly based on whether the administrative opposite has the obligation of administrative filing. Mandatory filing means that the administrative relative must apply to the filing authority for the record in accordance with the prescribed time limits and procedures, and complete the filing procedures, which has been recognized by the administrative organ and is conducive to strengthening supervision and management. At present, most of China's filing is mandatory filing, in regulations, normative documents are generally expressed as "should" for the record. Arbitrary filing means that administrative relatives can decide whether or not to file, the law has no mandatory requirements, in practice less. If Article 25 of the Regulations on the Implementation of the Copyright Law stipulates that "a contract for exclusive licensing or transfer with the copyright owner may be filed with the copyright administrative department", article 17, paragraph 2, of the Regulations on Motor Vehicle Registration stipulates that "if the name or number of the identity of the owner of a motor vehicle changes, it may apply to the vehicle management office at the place of registration for the record".
is to file in front of and after the record. Pre-filing generally refers to the administrative relative who, before making the corresponding act, reports to the filing authority matters requiring administrative filing in accordance with the law. Article 57 of the Measures for the Registration and Administration of Medical Devices stipulates that "before the production of a class 1 medical device, the product shall be filed", that is, the pre-record shall be provided for through the regulations.
of filings required by laws, regulations, and regulations are after-the-fact filings, which is also an important difference between filing and licensing. The filing materials filed by the filing organ to the administrative relative generally only fulfill the obligation of formal examination, which is different from the substantive examination and pre-control of the administrative license.
the current provisions of the administrative record of food and drug supervision
China's current food and drug regulatory laws, regulations and regulations related to the administrative filing provisions of a total of 27. Article 76 of the newly amended Food Safety Law provides for the filing of health food, and Article 40 of the Drug Administration Law provides for the filing of imported medicines.
Special Provisions of the State Council on Strengthening the Safety Supervision and Administration of Food and Other Products, Regulations on the Implementation of the Drug Administration Law, Anti-Doping Regulations, Regulations on the Administration of Narcotic Drugs and Psychotic Drugs, Regulations on the Supervision and Administration of Medical Devices and other administrative regulations respectively provide for the filing of clinical trial institutions, the filing of imported drugs, the filing of enterprises that advertise, the filing of medical device products and the filing of clinical trials.
Measures for the Registration and Filing of Health Food, Measures for the Investigation and Punishment of Internet Food Safety Violations, Measures for the Administration of Drug-type Easy-to-Drug Chemicals, Regulations on quality management of drug clinical trials, Measures for the Administration of Drug Importation, Measures for the Administration of Drug Production Supervision and Administration, Measures for the Administration of Imported Pharmaceuticals (Trial), Measures for the Review of Drug Advertising, Measures for the Administration of Drug Registration, Measures for drug Recall Regulations such as the Measures for the Administration of Medical Device Registration and Management respectively provide for the filing of health food, the filing of third-party platforms for online food transactions, the filing of unilateral preparations for the transfer of drug-type easy-to-use chemicals, the filing of ethics committees, the filing of changes in drug commissioning processing and production conditions, the filing of pharmaceutical advertisements, the filing of drug recall plans, and the filing of medical device products.
In addition to the laws, regulations and regulations on food and drug supervision, there are also a large number of normative documents to regulate the field of food and drug production and operation, guide the research and development, production and operation of administrative relatives, and supervise and guide the administrative law enforcement behavior of the lower food and drug regulatory departments, among which there are more filing provisions. For example, Article 7 of the Regulations on the Administration of the Filing of Imported Processed Drugs Commissioned by Foreign Pharmaceutical Manufacturers (State Food and Drug Administration No. 541), which come into effect on January 1, 2006, stipulates that pharmaceutical production enterprises entrusted shall file with the Food and Drug Administration of the provinces, autonomous regions and municipalities directly under the Central Government.
inadequate administrative filing system for food and drug supervision
inconsistent use of the concept
First, the confusion between external filing and internal filing. Internal filing generally refers to a specific way of hierarchical supervision between administrative organs at the upper and lower levels, and external filing is when the administrative relative declares information to the food and drug regulatory department in accordance with the provisions of laws, regulations and regulations for filing, disclosure and convenience for daily inspection by the food and drug regulatory department. In the food and drug regulations and regulations, there are a large number of external filing and internal filing mixed situation, some regulations, normative documents, there are both external filing and internal filing, and all use the word "filing", often to the regulatory authorities and administrative relatives to bring difficulties in understanding. For example, both the Measures for the Review of Drug Advertising and the Measures for the Administration of the Registration of Medical Institutions (Trial) provide for both external and internal filings in a regulation, but do not distinguish between terms.
is the confusion between administrative filing and administrative licensing and administrative confirmation. Administrative licensing, administrative confirmation and administrative filing are different administrative acts, and the concept and scope of application are clearly defined by laws, regulations, regulations and other forms, but due to the unclear definition of the record, there are many meanings in the administrative record of food and drug supervision. If there is no significant difference between the prescribed filing procedure and the administrative license in the "licensed filing" of drug import and cosmetics import management, the administrative relative shall not file if he or she does not meet the requirements of the record.