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27-455: By testing medicines independently of manufacturers (that is, without any conflict of interest and with guaranteed impartiality), OMCLs play a fundamental role in ensuring the quality and contributing to the safety and efficacy of medicines, whether already on the market or not, for human and veterinary use. OMCLs assess human and veterinary medicines to determine whether they meet the relevant requirements for content, purity, etc., as specified in

54-511: A marketing authorisation already granted may be withdrawn, suspended or revoked. The application dossier for marketing authorisation is called a New Drug Application (NDA) in the USA or Marketing Authorisation Application (MAA) in the European Union and other countries, or simply registration dossier. This contains data proving that the drug has quality, efficacy and safety properties suitable for

81-401: A one-page document called certificate of registration (and containing minimal data identifying the product and its source). Authorisation processes follow either a purely national procedure, with rules and requirements as per national legislation in force, as it occurs in most of countries worldwide, or should follow a centrally approval or a mutual recognition of decentralised procedures within

108-457: A single sequence may be viewed with web browser and the ICH stylesheet provided, viewing a cumulative eCTD requires specialized eCTD viewers. The top part of the directory structure is as follows: The string ctd-123456/0000 is just an example. This is the file index.xml in the submission sequence number folder . For example: The purpose of this file is twofold: Stylesheets that support

135-462: Is a big transition for China to move from paper submission to eCTD submissions. The Japan PhMDA has been eCTD compliant at least since December 2017. The Electronic Common Technical Document Specification, the main ICH standard, largely determines the structure of an eCTD submission. However, additional specifications may be applied in national and continental contexts. In the United States,

162-580: Is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). Version 2.0 of eCTD – an upgrade over the original CTD – was finalized on February 12, 2002, and version 3.0

189-439: Is still favourable. However, in the European Union, after one renewal, the marketing authorisation shall remain valid for an unlimited period, unless the competent regulatory authority decides otherwise. If the marketing authorisation is not renewed in due time as requested by the local legislation, in order to maintain the pharmaceutical product on a market, one can apply for re-authorisation (re-registration). In such situations,

216-615: The Food and Drug Administration (FDA) layers additional specifications onto its requirements for eCTD submissions, including PDF, transmission, file format, and supportive file specifications. In the European Union, the European Medicines Agency's EU Module 1 specification as well as other QA documents lay out additional requirements for eCTD submissions. The eCTD has five modules: A full table of contents could be quite large. There are two categories of modules: The CTD defines

243-506: The electronic Common Technical Document (eCTD). The application is filed with the regulator, which can be either an independent regulatory body or a specialised department in the ministry of health. Depending on jurisdiction, the resulting document may be more detailed (in addition to data identifying the product and its marketing authorisation holder), for example containing addresses of all manufacturing sites, appended labelling, artwork of packaging components, etc. or may be simplified to

270-487: The marketing authorisation dossier or an official pharmacopoeia. They can also check whether packaging and labelling comply with legal requirements, and provide support during quality assessment, good manufacturing practice (GMP) inspections and investigations of quality defects and pharmacovigilance . Investigations may also be carried out on products suspected of being falsified, in support of police, customs, health or judicial authorities. OMCLs also actively contribute to

297-523: The EDQM homepage. The network supports laboratories across Europe in making the best use of their expertise, technical capacity and financial resources, in order to ensure the appropriate control of medicines in Europe. This is done by organising co-ordinated testing programmes, meetings, training, audits and tailored Proficiency Testing Schemes (PTSs) and by providing the necessary (IT) infrastructure. The activities of

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324-433: The European Union. The type of application may vary according to status of the active ingredient. Thus, if the application concerns a new active ingredient (new active substance, new chemical entity, new molecular entity), one talks about a full application. Once a new active ingredient is authorised, any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations (changes to

351-799: The GEON are co-funded by the Council of Europe and the European Union . OMCLs play an essential role in the Official Control Authority Batch Release (OCABR) procedure, which is foreseen in EU legislation. Under this procedure, each batch of vaccine for human use, medicinal product derived from human blood or plasma (e.g. clotting factors, human albumin) or immunological veterinary medicinal product (e.g. veterinary vaccine) undergoes independent quality control, including testing, by an OMCL after release by

378-570: The applicant may be requested to submit the whole items necessary for a full application. Marketing authorisation may be withdrawn, suspended, revoked or varied by regulatory authorities if under normal conditions of use the benefit over risk ratio is no more favourable, the product is harmful, or if it lacks therapeutic efficacy; also, one of the above actions can be taken if the qualitative and quantitative composition or other qualitative aspects (control) are not as currently declared. Marketing authorisation may be also withdrawn, suspended or revoked if

405-461: The content only of the common modules. The contents of the Regional Module 1 are defined by each of the ICH regions (USA, Europe and Japan). The eCTD is a message specification for the transfer of files and metadata from a submitter to a receiver. The primary technical components are: Each submission message constitutes one "sequence". A cumulative eCTD consists of one or more sequences. While

432-586: The development and verification of pharmacopoeial methods. To take into account the cross-border and global dimension of medicines markets, OMCLs co-operate actively at the European level and beyond. They do so through the General European OMCL Network (GEON), which was set up jointly by the Council of Europe and the European Commission (EC) in 1995. A number of non-European OMCLs have joined

459-401: The evidence to support a medicinal product, such as a drug, in relation to its marketing, finalised by granting of a licence to be sold. This process is performed within a legal framework defining the requirements necessary for successful application to the regulatory authority, details on the assessment procedure (based on quality, efficacy and safety criteria), and also the circumstances where

486-525: The existing marketing authorisation) and extensions shall also be granted an authorisation or be included in the initial marketing authorisation, being subject of an abridged application. Special consideration is to be given to application for authorisation of biological products and biotechnology products, homeopathic products, herbal drugs, radionuclide generators , kits, radionuclide precursor radiopharmaceuticals and industrially prepared radiopharmaceuticals; in such instances, requirements are specific, in

513-473: The intended use, additional administrative documents, samples of finished product or related substances and reagents necessary to perform analyses of finished product as described in that dossier. The content and format of the dossier must follow rules as defined by the regulator. For example, since 2003, the authorities in the United States, the European Union and Japan ask for the Common Technical Document (CTD) format, and more recently, its electronic version –

540-448: The manufacturer and before it reaches the patient. The legislation requires mutual recognition of test results among the member states (EU/EEA), so the OMCLs involved work together as a network to ensure that any batch is tested in only one OMCL, under agreed conditions, for the benefit of all. Marketing authorisation Marketing authorisation is the process of reviewing and assessing

567-543: The marketing authorisation holder or its representative does not fulfil other legal or regulatory obligations necessary to maintaining of product on the market, as per the legislation in force. Also, the marketing authorisation is withdrawn in the EU if the product is not placed on the market within next 3 consecutive years after granting of authorisation or if it is no more marketed for 3 consecutive years (so-called “sunset clause”). Electronic Common Technical Document The electronic common technical document ( eCTD )

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594-417: The meaning that they are special, more or less detailed, as per the nature of active ingredient. In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product

621-529: The network as associate members. The GEON, which comprises over 70 OMCLs from over 40 different countries, is co-ordinated by the Strasbourg-based European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe , an international organisation upholding human rights, democracy and the rule of law in Europe. A list of network members is publicly available on

648-467: The presentation and navigation should be included. They must be placed in the directory: See entry 377 in Appendix 4. DTDs must be placed in the directory: See entries 371–76 in Appendix 4. They must follow a naming convention. The DTD of the backbone is in Appendix 8. It must be placed in the above directory. The business process to be supported can be described as follows: The lifecycle management

675-776: Was a sponsor and an early adopter of the eCTD workflow, especially for its Health Products and Food Branch regulator, but as of April 2015 had not yet fully automated it. The E.U. and its European Medicines Agency began accepting eCTD submissions in 2003. In February 2015, the "EMA announced it would no longer accept paper application forms for products applying to the centralized procedure beginning 1 July 2015." The EMA verified on that date that it would no longer accept "human and veterinary centralised procedure applications" and that all electronic application forms would have to be eCTD by January 2016. In November 2017, China Food and Drug Administration (CFDA) publishes draft eCTD structure for drug registration for public consultations. This

702-530: Was an ICH "teleconference" to discuss the guidance and any queries or clarifications that might be necessary. On May 5, 2015, the U.S. Food & Drug Administration published a final, binding guidance document requiring certain submissions in electronic (eCTD) format within 24 months. The projected date for mandatory electronic submissions is May 5, 2017 for New Drug Applications (NDAs), Biologic License Applications (BLAs), Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs). Health Canada

729-619: Was finalized on October 8 of the same year. As of August 2016 , the most current version is 3.2.2, released on July 16, 2008. A Draft Implementation Guide (DIG) for version 4.0 of eCTD was released in August 2012. However, work stalled on the project. An additional Draft Implementation Guide was released in February 2015 The ICH and the FDA released draft specifications and guides in April 2016, and on May 13 there

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