Medical network May 23 - the food and drug supervision bureau issued on August 9, 2016 on the medicine packaging material for examination and approval of pharmaceutical excipients associated with drug review announcement of relevant matters of no. 134 (2016), released on November 23, 2016 "about pharmaceutical excipients declaration data release drug packaging material requirements (trial) circular no. 155 (2016). Now the relevant content is read as follows: 

 

What are the requirements for the declaration of the application for the application for the application for the application for the application for the application for the application of the medical materials and medical materials? 

 

Publicly listed company in drug clinical trial application stage, preparation of unused drugs packaging, pharmaceutical excipients, should be related to declare the applicant for or by the drug registration in accordance with the 2016 announcement no. 155 is to be submitted to research data; Other drug packaging, pharmaceutical excipients, drug registration applicant shall be at least the data of drug registration application, provide relevant medicine packaging, pharmaceutical excipients production enterprise information, product basic information, quality standards and inspection report and related data. 

 

Not in drug clinical trial application stage for all submitted or research related personal data, related drug packaging, pharmaceutical excipients production enterprises shall be listed on the drug application stage for associated declaration or by the drug registration applicant submitted in accordance with the requirements for circular no. 155 2016 all the research data. 

 

Are the materials and medical supplements available for the relevant declaration of the supplement application? 

 

Drug registration applicant according to the "drug registration management approach" annex 4 item 1, item 6 and 10 additional application matters, or according to the regulations on the drug technology transfer registration (the food drug safety note [2009] no. 518) to apply for additional 12, medicine packaging, pharmaceutical excipients declaration can be associated with the supplementary application. 

 

What is the requirement of the "development of 3.5 manufacturing process" for the notification of annex 1 of the annex 1 medical auxiliary materials? 

 

Pharmaceutical excipients production enterprise should according to the nature of complementary makings, development situation and the historical evolution and function in the preparation, provide detailed information for the use of the review as soon as possible. If the particulars are not provided, the reasons and grounds shall be explained. 

 

What are the requirements for the circulation of the medical and medical materials? 

 

Medicines and their associated medicine packaging, pharmaceutical excipients to declare the applicants in the same province, provincial food and drug supervision and administration department shall present the corresponding drugs and associated medicine packaging, pharmaceutical excipients declaration to declare data synchronization to send to the food and drug supervision administration center of drug approval; Not in the same province, drug registration applicant shall promptly pay close attention to the progress of the medicine packaging material, application of pharmaceutical excipients associated, make sure to declare data synchronization send food and drug supervision administration center of drug approval. 

 

The food and drug supervision administration of drug approval centre for drug registration application and its associated medicine packaging materials, to declare the declaration data of pharmaceutical excipients, declare all information, start technical review. 

 

Do you need to submit a supplementary application after the approval of the approval certificate for the approval of the approved materials and medical supplies? 

 

Where the information has been altered by the approval of the approved information, the application for examination and approval shall not be made separately. The enterprise of pharmaceutical and medicinal materials should carry out the corresponding research work, and promptly inform the relevant pharmaceutical production enterprises. Drug manufacturers should make changes to the drugs involved in order to ensure the quality of medicines. The general administration of food and drug administration is in the process of formulating relevant regulations on the management of change management for pharmaceutical and pharmaceutical materials. 

 

What are the ingredients and medical supplements that are not allowed to continue? 

 

The state shall publish a ban on the use or elimination of medicinal materials and medicinal materials and shall not continue to be used in the original drugs. 

 

Is the raw material used in the production process of the pharmaceutical packaging related declaration? 

 

The raw materials used in the production of pharmaceutical packaging shall not be included in the scope of examination and approval. For example, we need to continue processing of moulded glass tubes, rubber and elastomer, plastic granules, and various additives, additives, fillers, etc. 

 

Are the adjuvants used in the research and development of biological products associated with the declaration? 

 

The adjuvant used in the research and development of biological products shall conform to the requirements of the registration administration of biological products and shall not be included in the scope of examination and approval. 

 

9, what is the requirement for the pharmaceutical products that have been produced with the drug? 

 

For injection, such as eye drops for drug registration, and drug collinear supporting the production of plastic bags, bottles and other packaging materials, by the applicant for drug registration in accordance with the relevant provisions of no. 155, 2016 notices submitted research materials, after the review does not issue the approval number. The packaging materials, such as plastic bags and bottles, which are manufactured by the drug collline, are only for the use of medicines produced by the enterprise. 

 

What are the requirements for the application of import supplementary materials accepted before the announcement of the no.134 announcement in 2016? 

 

Before announcement no. 134 in 2016 has been accepted, the application for registration of the import materials for clinical trials listed applications filed after the approval documents, the applicant shall continue to apply for the listed as stipulated. 

 

What are the medical supplements that are not included in the examination and approval in annex 1 of the article 134 of 2016? 

 

Taste masking agent (agent) : such as sucrose, single syrup, mannitol, sorbitol, sodium saccharin, division o Tampa, sucralose, stevia sugar, glucose, xylitol, maltitol, etc. This type is restricted to the use of a reagent (sweetener) in the preparation. 

 

(2) essence and spices: orange essence, banana essence, vanilla etc. The implementation of food standards, should comply with the current edition of GB 2760 "standard of national food safety standards of using food additives", GB 30616 "national food safety standards Food with essence and GB 29938 "general principles of the national food safety standards of food with spices and other related requirements. 

 

(3) pigment (coloring agent) : such as iron oxide, plant black, cochineal insect red, etc. The implementation of the food standards shall comply with the requirements of the existing GB 2760 food safety standards for food safety standards. 

 

(4) pH regulator (including pH regulator used in the injection), such as malic acid, fumaric acid, acetic acid, sodium acetate, citrate (sodium, potassium), tartaric acid, sodium hydroxide, concentrated ammonia solution, hydrochloric acid, sulfuric acid, phosphoric acid, lactic acid, potassium dihydrogen phosphate, potassium hydrogen phosphate, disodium hydrogen phosphate, sodium dihydrogen phosphate, etc. 

 

(5) is only used as auxiliary materials, simple preparation technology, stable physical and chemical properties of inorganic salts (including injection used in inorganic salts) : such as calcium carbonate, sodium carbonate, potassium chloride, calcium chloride, magnesium chloride, calcium phosphate, calcium hydrogen phosphate and calcium sulfate, sodium bicarbonate, etc. 

 

(6) the non-benzene ink used in the use of oral preparations. 

 

The above-mentioned medical supplementary materials, the current edition of the Chinese pharmacopoeia, should meet the requirements of the current edition of the Chinese pharmacopoeia; If the current edition of the Chinese pharmacopoeia is uncollected, it shall meet the national food standards or the current standard of USP/NF, EP, BP and JP pharmacopoeia. Other supplementary materials shall meet medical requirements. 

 

Drug registration applicant for drug registration, it shall, at least in the data of drug registration application, provide pharmaceutical excipients production enterprise information, product basic information, production process, product quality standard, inspection report and related data. The above supplementary materials shall complete the association review without the approval number. 

 

The general administration of food and drug administration will adjust and improve the medicinal materials that are not included in the scope of examination and approval according to the work.