The European Medicines Agency (EMA) supports the development of medicines that address unmet medical needs. In the interest of public health, applicants may be granted a conditional marketing authorisation for such medicines on less comprehensive clinical data than normally required, where the benefit of immediate availability of the medicine outweighs the risk inherent in the fact that additional data are still required. Show
Medicines for human use are eligible if they are intended for treating, preventing or diagnosing seriously debilitating or life-threatening diseases. This includes orphan medicines. Its use is also intended for a public health emergency (e.g. a pandemic). For these medicines, less comprehensive pharmaceutical and non-clinical data may also be accepted. The legal basis is Article 14-a of Regulation (EC) No 726/2004. The provisions for granting a conditional marketing authorisation are further elaborated in Regulation (EC) No 507/2006. Criteria and conditionsEMA's CHMP may grant a conditional marketing authorisation for a medicine if it finds that all of the following criteria are met:
Conditional marketing authorisations are valid for one year and can be renewed annually. Once a conditional marketing authorisation has been granted, the marketing authorisation holder must fulfil specific obligationswithin defined timelines. These obligations could include completing ongoing or new studies or collecting additional data to confirm the medicine's benefit-risk balance remains positive. EMA publishes the conditions of the marketing authorisation in the medicine's European public assessment report. The marketing authorisation can be converted into a standard marketing authorisation (no longer subject to specific obligations) once the marketing authorisation holder fulfils the obligations imposed and the complete data confirm that the medicine's benefits continue to outweigh its risks. Initially, this is valid for 5 years. It can then be renewed for unlimited validity. As for any medicine, if new data show that the medicine’s benefits no longer outweigh its risks, EMA can take regulatory action, such as suspending or revoking the marketing authorisation. EMA can also take regulatory action if the company does not comply with the imposed obligations.  Conditional marketing authorisation is a pragmatic tool for the fast-track approval of a medicine that fulfils an unmet medical need. Despite earlier approval, it guarantees that the medicine meets rigorous EU standards for safety, efficacy and quality and that comprehensive data is still generated post-approval. It offers a robust post-authorisation regulatory framework based on legally binding obligations, safeguards and controls. These include:
Use during COVID-19 pandemicGuidance for applicantsDistinction from authorisation under exceptional circumstancesLatest statistics10-year review (2006-2016)The report shows that conditional marketing authorisation can help speed up patient access to new medicines. It also calls for further improvements, including wider use of early dialogue between EMA and applicants and engaging further stakeholder groups, such as health-technology-assessment bodies. Which act requires companies who store financial or personal data to have an adequate security plan and system in place?Privacy and Security
The Gramm-Leach-Bliley Act requires financial institutions – companies that offer consumers financial products or services like loans, financial or investment advice, or insurance – to explain their information-sharing practices to their customers and to safeguard sensitive data.
In what ways has social media influence a company's ability to outsource?In what way, if any, has social media influenced a company's ability to outsource? Social media increases the outsourcing abilities of both large and small companies.
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These can be renewed an unlimited number of times if they are used for business purposes
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