API is the dominant sector for China pharmaceutical industry to participate in international competition. Since the outbreak of New Crown Pneumonia, the global pharmaceutical industry chain has been impacted, further enhancing the strategic position of China's API industry. According to the statistics of the National Development and Reform Commission, China can produce almost all kinds of APIs, exceeding 1500, of which 60% are exported. By the end of 20 19, China's APIs had been exported to 189 countries and regions, mainly in Asia, Europe and North America. International certification is a necessary procedure for export. The export of APIs needs to submit a large number of product-related materials to the local government or relevant institutions for certification before export. If the API is exported from a country other than the same language, the submitted materials and various explanatory documents need to be translated. The format of relevant materials required for API certification is very strict, and there are many technical terms, which is very difficult.
API certified translators can obtain certification faster and better through the following qualifications:
Translation is a major in pharmacy or medicine.
Familiar with the certification process and related policies of various countries.
Familiar with authentication data format and related terminology.
There are three kinds of API certification in the world: FDA certification in the United States, EDQM certification in Europe and PMDA certification in Japan.
FDA certification
The FDA certification in the United States is divided into five categories: Class I-production sites and factory facilities, Class II-intermediates, APIs and drugs, Class III packaging materials, Class IV excipients, colorants, spices, flavors and other additives, and Class V non-clinical data and clinical data.
Generally speaking, the application and certification procedures of China manufacturers are as follows:
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EDQA certification
CEP in Europe is only applicable to APIs with European Pharmacopoeia (EP) standards, that is, the varieties of APIs recorded in EP.
The basic procedures for applying for cultural education include:
PMDA certification
Japan's PMDA certification can only be submitted to the PMDA official through Japanese domestic managers, not directly by themselves.
The basic procedures for applying for microfinance include:
No matter which country's application, it is inseparable from CTD documents, GMP inspection reports, official amendments and queries, supplementary documents and reply instructions. The different cultural backgrounds of different countries make language the most urgent problem to overcome.
country
Modify opinions and questions
Supplementary documents and reply instructions
United States of America
483 table problem
On-site inspection and reply instructions of Table 483
Europe
Revised opinions put forward by EDQM
Supplementary explanation of GMP inspection reply
Japan
Defects proposed by PMDA
Reply to defects raised by PMDA
Typesetting requirements of CTD
The expression of information in CTD should be clear, and the applicant should not modify the overall structure of CTD to facilitate the review and quick retrieval of content.
Paper size: Europe and Japan -A4, American stationery (8.5X 1 1 ``), and documents and forms should be printed on paper. The left margin should ensure that the binding is not affected.
Font: The characters of documents and tables should be large enough for clear reading. For descriptive documents, it is recommended to use the time-new Roman character (12).
Abbreviations should be defined when they are first used in each module.
Every page must have a numbered page number
Requirements of DMF document M 1
Letter (Home Page)
Statement of Commitment (Statement Letter)
Management Page (Management Information)
Letter of appointment of American agent (designated American agent)
authorization letter
Letter of transfer of holder's name (transfer of certificate holder)
Letter of acceptance from new holder (letter of acceptance from new holder)
Request (cancel, close) DMF (cancel and close DMF)
Patent status (patent statement)
Requirements of European CEP application document M 1
Application form/application
authorization letter
Statement when the manufacturer is not the intended holder of the certificate of suitability.
A statement of willingness to be examined.
Letter of Declaration on Substances of Animal/Human Origin (TSE Risk Statement)
Letter of commitment to provide samples at the request of edqm (statement of willingness to provide samples).
Module M2: Quality Overview
project
2.3.S. 1 basic information
2.3.S. 1. 1 drug name
2.3.S. 1.2 structure
2.3.S. 1.3 physical and chemical substances
production information
2.3.S.2. 1 manufacturer
Production technology and process formulation
Material control
Key steps and intermediate control
Process verification and evaluation
2.3.S.2.6 production process development
Structural confirmation
2.3.S.3. 1 structure and physical and chemical properties
impurity
2.3.S.4 Control of APIs
2.3.S.4. 1 quality standard
Analytical method
Verification of analytical methods
2.3.S.4.4 Batch inspection report
2.3.S.4.5 Basis for formulating quality standards
2.3.S.5 reference materials
2.3.S.6 packaging materials and containers
stability
2.3.S.7. 1 stability summary
List stability commitments and stability plans.
Stability data summary
Module M3: Quality Section
project
3. 1 directory
3.2.S APIs
3.2.S. 1 general information
3.2.S. 1. 1 naming
3.2.S. 1.2 chemical structure
3.2.S. 1.3 general characteristics
produce
3.2.S.2. 1 manufacturer
Description of production technology and process control
Material control
3.2.S.2.4 Key process steps and intermediate control
3.2.S.2.5 process verification
Improvement and change control of production process
architectural feature
3.2.S.3. 1 structural features and other characteristics
impurity
3.2.S.4 API control
3.2.S.4. 1 quality standard
Analytical method
Verification of analytical methods
Batch analysis report
Rationality analysis of quality standards
3.2.S.5 reference materials
3.2.S.6 Packaging containers and sealing methods
stability test
3.2.S.7. 1 stability experiment summary and conclusion
3.2.S.7.2 After the application for stability test scheme and stability guarantee is approved.
Stability test results list
Yaris Medical Translation has been focusing on the translation of medicines and medical devices, with hundreds of full-time translation experts in the fields of pharmacy, medicine, physics, biology, manufacturing and engineering. The Medical Translation Department consists of professional translators with backgrounds in pharmacology, toxicology, pharmacognosy, medicinal chemistry, pharmaceutical analysis, pharmacy, clinical medicine and clinical pharmacology. They have all worked and studied in pharmaceutical factories or university pharmacy schools, and are very familiar with the translation of complete sets of documents of DMF, IND and AND. Most members have a master's degree or above in medicine or pharmacy.