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This Guide applies to the manufacture of APIs for medicinal products for both human and veterinary use. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered but should be performed in accordance with the principles and guidelines of GMP as laid down in national legislations and interpreted in the GMP Guide including its Annex 1.

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The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation or Clinical Trial Authorisation, as appropriate, and do not place patients at risk due to inadequate safety, quality or
efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers, and by its distributors. To achieve this quality objective reliably there must be a comprehensively designed and correctly implemented Pharmaceutical Quality System incorporating Good Manufacturing Practice and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Pharmaceutical Quality System should be adequately resourced with
competent personnel, and suitable and sufficient premises, equipment, and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Authorised Person(s).

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The electronic application form has been prepared to be filled in by the applicant in case of an application made either by national route or by mutual recognition, decentralised or centralised procedures.

In the case of a mutual recognition or decentralised procedure an application form should be filled in for all competent authorities where the application is made.

The same applicant should apply in all concerned member states. Since some information may differ between member states (e.g. marketing authorisation holder/registration holder, legal status, contact persons etc.), the appropriate sections should be replicated where necessary.

This guideline also describes following points;

  1. Type of application
  2. Marketing Authorisation Application particulars
  3. Scientific Advice
  4. Other Marketing Authorisation Applications

 

 

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The guidance provided by the working group in the form of questions and answers (Q&As) provides additional interpretation of the European Union (EU) GMP guidelines and GDP guidelines published by the European Commission.

This guideline describes following points;

  • EU GMP guide part I: Basic requirements for medicinal products: Chapter 3: Equipment
  • EU GMP guide part I: Basic requirements for medicinal products: Chapter 3: Shared manufacturing facilities
  • EU GMP guide part I: Basic requirements for medicinal products: Chapter 5: Production
  • EU GMP guide part I: Basic requirements for medicinal products: Chapter 8: Complaints, Quality Defects and Product Recalls
  • EU GMP guide part II: Basic requirements for active substances used as starting materials: GMP compliance for active substances
  • EU GMP guide part II: Basic requirements for active substances used as starting materials: GMP compliance for active substances in investigational medicinal products (IMPs)
  • EU GMP guide annexes: Supplementary requirements: Annex 6: Manufacture of medicinal gases etc..
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The only differences between an eCTD and a non-eCTD electronic submission in each case should therefore be that:

  • The index.xml and eu-regional.xml files, and the util folder containing other technical eCTD components, are omitted from a non-eCTD electronic submission;
  • A non-eCTD electronic submission should contain dynamic table of content documents to facilitate navigation, (such ToCs do not form part of the eCTD as the function is provided by the eCTD XML backbone).
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This guidance document explains the principal factors that FDA considers when making benefit-risk determinations in the premarket review of certain medical devices. The processes discussed in this guidance are applicable to devices subject to premarket approval (PMA) applications or De Novo classification requests. This guidance applies to both diagnostic and therapeutic devices. The concepts discussed in this guidance are applicable to the medical device development process from design to market. As such, the benefit-risk factors set out herein should be considered during the design, non-clinical testing, Pre-Submission, and Investigational Device Exemption (IDE) phases as well as in assembling and assessing PMA applications or De Novo requests. Although guidance is not binding, the concepts and factors described herein generally explain how benefit-risk determinations are made by FDA during the premarket review process.

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