What are the requirements for a drug registration applicant? 200

You need to have the "Drug Registration Application Form", and secondly, there are the requirements for reading and analyzing the drug registration materials in different countries;

2. Prepare the corresponding registration materials according to the requirements of foreign drug registration;

3. Familiar with the analysis methods of raw materials and finished products of a variety of commonly used dosage forms;

4. Go to the pharmaceutical factory to participate in the sample inspection of the drug to be registered;

5. Supervise the quality of drugs on site during the order production period;

6. Be able to design drug inspection methods together with factories and technicians;

7. Be able to compile production records, raw materials and finished product inspection reports, stability reports and other information.

Years of experience in drug testing;

3. Proficient in reading and writing foreign language materials;

4. Proficient in the use of network search.

The drug registration applicant refers to the unit that has obtained the qualification to apply for drug registration and intends to apply for drug registration.

The applicant for drug registration shall meet the following conditions:

1.The applicant is a drug development and drug manufacturing enterprise established in accordance with the law, and meets the relevant requirements of drug registration.

2.It has a plant, facilities and sanitary environment suitable for the scale of production, and has quality management and quality assurance measures.

3.It has maintenance, storage, measurement, inspection and sales personnel suitable for the drugs produced, and meets the relevant requirements of drug registration.

4.Have production personnel and quality management personnel suitable for the drugs produced, and meet the relevant requirements of drug registration.

5.Have equipment suitable for the drugs produced, and meet the relevant requirements of drug registration.

6.It has a plant and production environment suitable for the drugs produced, and meets the relevant requirements of drug registration.

7.Have a quality management organization or personnel suitable for the drugs produced, and meet the relevant requirements of drug registration.

The drug registration applicant is an institution that submits an application for drug registration, bears the corresponding legal responsibility, and holds the drug approval certificate after the application is approved. The domestic applicant shall be a legally registered legal entity, and the overseas applicant shall be a legal overseas pharmaceutical manufacturer.

1. What are the drug registration applications?

1) New drug application, which refers to the registration application of a drug that has not been marketed in China;

2) generic drug application, generic drug application refers to the registration application for the production of drugs with national standards that have been approved for marketing by the State Food and Drug Administration;

3) Application for imported drugs, which refers to the registration application for marketing and sales of drugs produced abroad in China;

4) Supplementary application, which refers to the registration application for changing, adding or canceling the original approved items or contents after the application for new drugs, generic drugs or imported drugs is approved;

5) Re-registration application, re-registration application refers to the registration application that the applicant intends to continue to produce or import the drug after the expiration of the validity period of the drug approval certificate.

2. Legal basis: Article 34 of the Measures for the Administration of Drug Registration.

After completing the research on pharmacy, pharmacology and toxicology and drug clinical trials to support the marketing and registration of drugs, determining the quality standards, completing the verification of the commercial-scale production process, and preparing to accept the verification and inspection of drug registration, the applicant shall submit an application for drug marketing authorization and submit relevant research materials in accordance with the requirements of the application materials. After the formal review of the application materials and the requirements are met, they will be accepted.

2. What are the requirements for applying for a drug patent?

The conditions for applying for a drug patent are:

1. The applicant for a patent for invention and utility model must have novelty, inventiveness and practicability;

2. The application for a design patent must be novel and not belong to the existing design; And none of them can conflict with the prior patent rights of others, and must not violate the law, violate social morality or harm the public interest.

Legal analysis: 1. New drug application.

A new drug application refers to a registration application for a drug that has not been marketed in China. For the registration of drugs that have already been marketed, such as changing the dosage form, changing the route of administration, and adding new indications, the registration of drugs shall be declared in accordance with the procedures for new drug applications.

2. Application for generic drugs.

The generic drug application refers to the registration application for the production of drugs with national standards that have been approved for marketing by the State Food and Drug Administration; However, biological products are declared in accordance with the procedures for new drug applications.

3. Application for imported drugs.

Application for import of drugs refers to the registration application for marketing and sale of drugs produced abroad in China.

4. Supplementary application.

Supplementary application chain balance refers to the registration application for changing, adding or canceling the original approved items or contents after the new drug application, generic drug application or imported drug application is approved.

5. Application for re-registration.

The application for re-registration refers to the registration application for the applicant to continue to produce or import the drug after the expiration of the validity period of the drug approval certificate.

Legal basis: Article 11 of the Measures for the Administration of Drug Registration Drug registration applications include applications for new drugs, generic drugs, imported drugs and their supplementary applications and re-registration applications. Domestic applicants shall apply for drug registration in accordance with the procedures and requirements for new drug applications and generic drug applications, and overseas applicants shall apply for import drug registration in accordance with the procedures and requirements for imported drug applications.

Legal Analysis: Drug registration refers to the process and activities in which the drug registration applicant (hereinafter referred to as the applicant) submits an application for drug clinical trial, drug marketing authorization, re-registration and other supplementary applications in accordance with legal procedures and relevant requirements, and the drug regulatory department conducts a review of safety, efficacy and quality controllability based on laws and regulations and existing scientific cognition, and makes a decision on whether to agree to its drug registration and its management application. After the applicant obtains the drug registration certificate, he or she is the holder of the marketing authorization of the drug (hereinafter referred to as the holder).

Legal basis: Measures for the Administration of Drug Registration

Article 3 refers to the process and activities in which the drug registration applicant (hereinafter referred to as the applicant) submits an application for drug clinical trial, drug marketing authorization, re-registration and other matters and supplementary applications in accordance with legal procedures and relevant requirements, and the drug regulatory department reviews the safety, effectiveness and quality controllability based on laws and regulations and existing scientific cognition, and decides whether to agree to its drug registration matters and its management application. After the applicant Tangming obtains the drug registration certificate, he is the marketing authorization holder of the drug (hereinafter referred to as the holder).

Article 4 Drug registration includes drug clinical trial application, drug marketing authorization application, supplementary application, re-registration application and other licensing matters, as well as other filing or reporting matters.

Legal analysis: To register a pharmaceutical company, the following conditions must be met:

1. Two licensed pharmacists, one of whom has a bachelor's degree or above;

2. The registered capital shall not be less than 500,000 yuan;

3. The legal person must have a college degree or above;

4. There is one acceptor, one conservator, and one custodian, and hold a GSP certificate;

5. Business personnel need to hold a purchase and sales staff certificate;

6. The warehouse is 500 square meters, of which the cold storage is not less than 3 square meters, and the cool storage is not less than 110 square meters;

7. There are necessary maintenance room instruments, including patent medicines and traditional Chinese medicine maintenance instruments.

Product trading enterprises must operate drugs in accordance with the "Good Management Standards for Drug Operation" formulated by the drug regulatory department. The drug regulatory department shall certify whether the drug trading enterprise meets the requirements of the "Good Practice for Drug Operation" in accordance with the regulations; If the certification is qualified, a certification certificate will be issued.

Legal basis: Article 23 of the Company Law of the People's Republic of China The establishment of a limited liability company shall meet the following conditions:

1) The shareholders meet the quorum;

2) There is a capital contribution subscribed by all shareholders in accordance with the provisions of the company's articles of association;

3) Shareholders jointly formulate the articles of association;

4) Have a company name and establish an organizational structure that meets the requirements of a limited liability company;

5) Have a company domicile.

When going to the Food and Drug Administration to apply for a drug business license, Kaituan needs to have more than three people with pharmacist qualifications in the He Bureau, that is, three certificates are required.

Registration procedure: The representative designated by all shareholders or the person jointly entrusted by the company shall apply for pre-approval of the name to the company registration authority, and apply for a drug business license with the pre-approval notice of the name of the company and the pharmacist qualification certificate to the Food and Drug Administration, and open an account with the bank with the name pre-approval notice, and then go to the accounting firm for capital verification, and after the capital verification report is issued by the accounting firm, bring the certificate of the designated representative of all shareholders or the co-entrusted person, the notice of pre-approval of the enterprise name, the capital verification report, The resolution of the shareholders' meeting (the resolution of the election of the representative of the magic weapon), the shareholder's ID card, the articles of association, the license, the proof of the business place, and the housing lease agreement shall be registered with the Industrial and Commercial Bureau. Then go to the tax bureau to apply for the tax registration certificate, and go to the quality supervision bureau to apply for the agency ** certificate.

Your company has a drug production license, and while waiting for GMP certification, you can apply for a new drug registration procedure, and you can't apply for it before it is approved for a drug production license. Drug registration is divided into traditional Chinese medicine, leaky chemical drugs, raw and deficient fiber products and supplementary applications, now the state is soliciting opinions on the drug registration management measures nationwide, domestic drug registration is basically in a state of stagnation, the general procedure of registration is: the application materials are submitted to the provincial bureau, the provincial bureau arranges on-site assessment, the assessment is passed, the provincial bureau reports to the national bureau, the national bureau transfers to the drug review center for technical review, and the review is unqualified or the supplementary information notice is issued, and the qualified ones are transferred to the national bureau for approval, and the new drug certificate and the approval of the search quasi-document number.

Drug registration applications include applications for new inflated drugs, applications for generic drugs, applications for imported drugs, supplementary applications and re-registration applications. Domestic applicants shall apply for drug registration in accordance with the procedures and requirements for new drug application and generic drug application.