User login
Photo courtesy of the FDA
The European Medicines Agency (EMA) has launched PRIME (PRIority MEdicines), an initiative intended to accelerate the development of drugs that target unmet medical needs.
These “priority medicines” may offer a major therapeutic advantage over existing treatments or benefit patients who currently have no treatment options in the European Union (EU).
Through PRIME, the EMA will offer early support to drug developers to optimize the generation of robust data on a treatment’s benefits and risks and enable accelerated assessment of an application for marketing authorization.
By engaging with developers early, the EMA aims to strengthen the design of clinical trials to facilitate the generation of high quality data to support an application for marketing authorization.
PRIME builds on the existing regulatory framework and available tools such as scientific advice and accelerated assessment.
To be accepted for PRIME, a treatment has to show the potential to benefit patients with unmet medical needs based on early clinical data.
Once a candidate medicine has been selected for PRIME, the EMA:
- Appoints a rapporteur from the Committee for Medicinal Products for Human Use (CHMP), or from the Committee on Advanced Therapies (CAT) in the case of an advanced therapy, to provide continuous support and help to build knowledge before a company submits an application for marketing authorization
- Organizes a kick-off meeting with the CHMP/CAT rapporteur and a multidisciplinary group of experts from relevant EMA scientific committees and working parties, and provides guidance on the overall development plan and regulatory strategy
- Assigns a dedicated EMA contact point
- Provides scientific advice at key development milestones, involving additional stakeholders such as health technology assessment bodies to facilitate quicker access to the new drug
- Confirms potential for accelerated assessment when an application for marketing authorization is submitted.
PRIME is open to all drug companies on the basis of preliminary clinical evidence. However, micro-, small- and medium-sized enterprises and applicants from the academic sector can apply earlier on the basis of compelling non-clinical data and tolerability data from initial clinical trials. They may also request fee waivers for scientific advice.
The EMA has released guidance documents on PRIME as well as a comprehensive overview of the EU early access regulatory tools—ie, accelerated assessment, conditional marketing authorization, and compassionate use.
The agency has also published revised guidelines on the implementation of accelerated assessment and conditional marketing authorization. These tools are reserved for treatments addressing major public health needs, and the revised guidelines provide more detailed information based on past experience.
Although PRIME is specifically designed to promote accelerated assessment, the EMA said the initiative will also help drug developers make the best use of other EU early access tools and initiatives, which can be combined whenever a drug fulfills the respective criteria.
PRIME was developed in consultation with the EMA’s scientific committees, the European Commission and its expert group on Safe and Timely Access to Medicines for Patients, as well as the European medicines regulatory network.
The main principles of PRIME were released for a 2-month public consultation in 2015, and the comments received were taken into account in the final version. 
Photo courtesy of the FDA
The European Medicines Agency (EMA) has launched PRIME (PRIority MEdicines), an initiative intended to accelerate the development of drugs that target unmet medical needs.
These “priority medicines” may offer a major therapeutic advantage over existing treatments or benefit patients who currently have no treatment options in the European Union (EU).
Through PRIME, the EMA will offer early support to drug developers to optimize the generation of robust data on a treatment’s benefits and risks and enable accelerated assessment of an application for marketing authorization.
By engaging with developers early, the EMA aims to strengthen the design of clinical trials to facilitate the generation of high quality data to support an application for marketing authorization.
PRIME builds on the existing regulatory framework and available tools such as scientific advice and accelerated assessment.
To be accepted for PRIME, a treatment has to show the potential to benefit patients with unmet medical needs based on early clinical data.
Once a candidate medicine has been selected for PRIME, the EMA:
- Appoints a rapporteur from the Committee for Medicinal Products for Human Use (CHMP), or from the Committee on Advanced Therapies (CAT) in the case of an advanced therapy, to provide continuous support and help to build knowledge before a company submits an application for marketing authorization
- Organizes a kick-off meeting with the CHMP/CAT rapporteur and a multidisciplinary group of experts from relevant EMA scientific committees and working parties, and provides guidance on the overall development plan and regulatory strategy
- Assigns a dedicated EMA contact point
- Provides scientific advice at key development milestones, involving additional stakeholders such as health technology assessment bodies to facilitate quicker access to the new drug
- Confirms potential for accelerated assessment when an application for marketing authorization is submitted.
PRIME is open to all drug companies on the basis of preliminary clinical evidence. However, micro-, small- and medium-sized enterprises and applicants from the academic sector can apply earlier on the basis of compelling non-clinical data and tolerability data from initial clinical trials. They may also request fee waivers for scientific advice.
The EMA has released guidance documents on PRIME as well as a comprehensive overview of the EU early access regulatory tools—ie, accelerated assessment, conditional marketing authorization, and compassionate use.
The agency has also published revised guidelines on the implementation of accelerated assessment and conditional marketing authorization. These tools are reserved for treatments addressing major public health needs, and the revised guidelines provide more detailed information based on past experience.
Although PRIME is specifically designed to promote accelerated assessment, the EMA said the initiative will also help drug developers make the best use of other EU early access tools and initiatives, which can be combined whenever a drug fulfills the respective criteria.
PRIME was developed in consultation with the EMA’s scientific committees, the European Commission and its expert group on Safe and Timely Access to Medicines for Patients, as well as the European medicines regulatory network.
The main principles of PRIME were released for a 2-month public consultation in 2015, and the comments received were taken into account in the final version.
Photo courtesy of the FDA
The European Medicines Agency (EMA) has launched PRIME (PRIority MEdicines), an initiative intended to accelerate the development of drugs that target unmet medical needs.
These “priority medicines” may offer a major therapeutic advantage over existing treatments or benefit patients who currently have no treatment options in the European Union (EU).
Through PRIME, the EMA will offer early support to drug developers to optimize the generation of robust data on a treatment’s benefits and risks and enable accelerated assessment of an application for marketing authorization.
By engaging with developers early, the EMA aims to strengthen the design of clinical trials to facilitate the generation of high quality data to support an application for marketing authorization.
PRIME builds on the existing regulatory framework and available tools such as scientific advice and accelerated assessment.
To be accepted for PRIME, a treatment has to show the potential to benefit patients with unmet medical needs based on early clinical data.
Once a candidate medicine has been selected for PRIME, the EMA:
- Appoints a rapporteur from the Committee for Medicinal Products for Human Use (CHMP), or from the Committee on Advanced Therapies (CAT) in the case of an advanced therapy, to provide continuous support and help to build knowledge before a company submits an application for marketing authorization
- Organizes a kick-off meeting with the CHMP/CAT rapporteur and a multidisciplinary group of experts from relevant EMA scientific committees and working parties, and provides guidance on the overall development plan and regulatory strategy
- Assigns a dedicated EMA contact point
- Provides scientific advice at key development milestones, involving additional stakeholders such as health technology assessment bodies to facilitate quicker access to the new drug
- Confirms potential for accelerated assessment when an application for marketing authorization is submitted.
PRIME is open to all drug companies on the basis of preliminary clinical evidence. However, micro-, small- and medium-sized enterprises and applicants from the academic sector can apply earlier on the basis of compelling non-clinical data and tolerability data from initial clinical trials. They may also request fee waivers for scientific advice.
The EMA has released guidance documents on PRIME as well as a comprehensive overview of the EU early access regulatory tools—ie, accelerated assessment, conditional marketing authorization, and compassionate use.
The agency has also published revised guidelines on the implementation of accelerated assessment and conditional marketing authorization. These tools are reserved for treatments addressing major public health needs, and the revised guidelines provide more detailed information based on past experience.
Although PRIME is specifically designed to promote accelerated assessment, the EMA said the initiative will also help drug developers make the best use of other EU early access tools and initiatives, which can be combined whenever a drug fulfills the respective criteria.
PRIME was developed in consultation with the EMA’s scientific committees, the European Commission and its expert group on Safe and Timely Access to Medicines for Patients, as well as the European medicines regulatory network.
The main principles of PRIME were released for a 2-month public consultation in 2015, and the comments received were taken into account in the final version.