What does a positive CHMP opinion mean?

What does a positive CHMP opinion mean?

The positive CHMP opinion is a scientific recommendation for marketing authorization and one of the final steps before the European Commission (EC) makes a decision on Karyopharm’s marketing authorization application (MAA).

What is CHMP scientific advice?

The questions raised during scientific advice and those addressed during the assessment of a medicine are fundamentally different: scientific advice addresses questions related to the most appropriate way to test and study a medicine; during the assessment of a medicine, the CHMP looks at the results of these studies …

What is mutual recognition procedure?

A procedure through which an authorisation of a medicine in one European Union Member State is recognised by another Member State.

What is a rapporteur EMA?

One of the two members of a committee or working party who leads the evaluation of an application.

How long does it take for the EMA to approve a drug?

Following a positive recommendation from the Agency, the European Commission takes around two months to approve a medicine.

How do I submit my scientific advice to EMA?

Apply using the ‘IRIS’ platform Scientific advice applicants need to upload a draft briefing document introducing the medicine under development and the applicant’s questions and positions in IRIS at the time of applying. EMA strongly recommends using its briefing document template for this purpose.

What Decentralised procedure?

The procedure for authorising medicines in more than one European Union Member State in parallel. It can be used for medicines that do not need to be authorised via the centralised procedure and have not already been authorised in any Member State.

How does the CHMP evaluate a medical product?

Assessments. The CHMP’s assessments are based on a comprehensive scientific evaluation of data. They determine whether the medicine meets the necessary quality, safety and efficacy requirements and that it has a positive risk-benefit balance. An internal peer-review system safeguards the accuracy and validity of the opinions of the committee.

How are CHMP opinions and EC decisions different?

So while CHMP opinions and EC decisions are typically in line with one another, agreement is not a guarantee. When looking at the relative speed between agencies, the use of this inappropriate endpoint of a cycle may create a not-so-valid comparison between EMA and FDA.

When does the CHMP give opinions on centralised marketing authorisation?

The CHMP gives opinions on centralised marketing authorisation applications at its monthly plenary meetings, which usually run from a Monday to a Thurs day. If the CHMP gives a positive opinion recommending the authorisation of a medicine , a summary of opinion

How does Committee for medicinal products for Human Use ( CHMP ) work?

They determine whether the medicine meets the necessary quality, safety and efficacy requirements and that it has a positive risk-benefit balance. An internal peer-review system safeguards the accuracy and validity of the opinions of the committee. How useful was this page?