Taking several years of hard work and effort to get to a point where a product can enter the market, it is crucial to develop a regulatory strategy as early as possible.
This helps to avoid delays and costs due to missing information and misleading strategic directions.
At any stage of development of a medicine, scientific advice can be requested from national competent authorities or the EMA. This can be on any aspect of the development. Scientific advice is important for any product to ensure that all regulatory requirements will be met by the final MAA. Timing is, therefore, crucial, to ensure that all development is valid and the overall procedure is efficient.
EUDRAC work with its clients to obtain Scientific Advice from the EMA and National Agencies. Through our experience of working with the different Agencies, we have a good understanding of their individual working practices and areas of expertise. We also provide a Regulatory Intelligence Service and so always have an up-to-date awareness of new and changing regulatory requirements. Our team has experience in a number of different therapeutic areas and we have a good understanding of key regulatory topics that will be addressed in Agency assessments.
We support your requests for scientific advice at the European Medicines Agency, whether it is during the initial development phase or during post-authorisation phase.
EMA encourages marketing authorisation holders and applicants to seek scientific advice for Post Authorisation Safety Study (PASS) protocols. Please contact us for further assistance.
As of summer 2017, the EMA offers parallel consultations with the European Network for Health Technology Assessment (EUnetHTA). This allows to get support for decisions regarding marketing authorisation and reimbursement.
For the development of biosimilars a pilot project was started at EMA in February 2017 to support scientists.
Protocol assistance is the special form of scientific advice available for developers of designated orphan medicines for rare diseases.
In addition to scientific advice, developers of orphan medicines can receive answers to questions relating to the criteria for authorisation of an orphan medicine.
In France, scientific advice meetings are free of charge, if eligibility criteria are met.
The ANSM would only answer to questions where related answers are not included in existing EMA or ICH guidelines, or if the Applicant seeks feedback on justified reasons to deviate from these guidelines. The scope of Scientific Advices is not pre-assessment of data, and the appropriateness or completeness of a CTA or MAA does not enter the scope of Scientific Advices, and are meant to be discussed directly at the level of the Product Division where the dossier will be assessed, and at their discretion. However, general recommendations on the development strategy, or the nature or details of studies to be completed before filing a CTA or a MAA may be discussed.
In order to be in a position to offer a slot for the organisation of a scientific advice meeting, the Scientific Advice Unit needs to receive first both a Request Letter and a Briefing Book.
The Request Letter will need to mention:
The Briefing Book will need to summarise, as shortly as possible,
In Germany BfArM has set up an innovation office, a special offer for small and medium-sized companies, start-ups and research centres as well as universities to seek advice in a kick off meeting.
The idea of this early support is to enable new and innovative products a fast and smooth market access and to avoid delays based on lack of regulatory experience.
This kick-off meeting has to be distinguished from a Scientific Advice Meeting, were a detailed scientific related information is topic of the consultation.
Scientific advice meetings in the UK can be held with the MHRA to discuss:
The MHRA also offers broader scope scientific advice, covering broader issues and not relating to only 1 development programme or product.
You can also have a joint meeting with MHRA and National Institute for Clinical Excellence (NICE).
In the European Union, a Paediatric Investigation Plan is an integral part of the Marketing Authorisation Application (MAA) for all drug types submitted via all routes of authorisation. Development of drugs for the paediatric population is an important consideration to be undertaken at an early stage in drug development.
It is important to know that in the European Union, the Paediatric Regulation 1901/2006 requires that a PIP is submitted soon after Phase 1 studies are completed.
Compliance with the agreed PIP will be checked either during the MAA or after the authorisation of the product, depending on the timelines for the studies agreed in the PIP.
EUDRAC advise, write and submit full Paediatric Investigation Plans for its clients. We also submit PIP modifications and provide Chemistry, Manufacturing and Controls (CMC) support for new paediatric formulations and regulatory advice on the paediatric requirements for an MAA.
An orphan drug designation is granted to drugs that are developed for rare diseases, providing that they fulfil the Agency’s criteria for “Orphan Designation”. Applications are reviewed by the Agency’s Committee for Orphan Medicinal products (COMP).
EUDRAC is involved in the development of a range of Orphan Drugs; we assist our clients with protocol assistance, clinical trial applications and HTA assessments. For a number of our clients we are the Regulatory representative for the Company.
The EMA PRIority MEdicines (PRIME) scheme supports the development of products for unmet medical conditions. Essentially, the EMA offer more advice on clinical trial design and overall development and regulatory strategy from an early stage. The aim is to ensure that the authorisation process is as efficient as possible.
EUDRAC will fully manage a PRIME eligibility request and further support our clients with subsequent scientific advice and protocol assistance. These are integral to the PRIME scheme and also for facilitating accelerated assessments of an MAA.
EUDRAC has successfully achieved PRIority MEdicines (PRIME) eligibility for a candidate medicine and is fully engaged in this early access scheme. We have a special interest in the development of drugs for conditions for which optimal treatments are not yet available. We work closely with our clients throughout this development process.
Clinical trials are mandatory for generation of reliable and robust data. They need to be authorised according to regulation (EU) No 536/2014 to guarantee protection and security to subjects.The regulation of clinical trials aims to ensure that the rights, safety and well-being of trial subjects are protected and the results of clinical trials are credible.
Clinical-trial data form a large part of the application dossiers submitted when applying for a marketing authorisation.
EUDRAC can review your documents and guide you through specific national requirements.
We support you with the application of your clinical trial and help to ensure the standards of GCP are applied.
EUDRAC and its partners will help to get all required information and conduct the application for you.
Clinical trials cannot be legally performed within a region without the authorisation of the trial by the regulators of the region. In the European Economic Area (EEA), the trial must be authorised by the national competent authority (NCA) and Ethics Committee (EC) for the region where the clinical trial is to take place.
The information and documents required by each NCA and EC vary, however usual requirements include (but are not limited to):
As part of EUDRAC’s research and development service, EUDRAC writes and submits all documents required for the successful acceptance of a clinical trial application. This can reduce time and resource required to learn the specific requirements within a region and the process of putting together a clinical trial application.
Changes to the protocol may require a substantial amendment of the clinical trial authorisation. Where this is necessary, the regulatory bodies in that region must authorise this amendment prior to the change being made within the clinical trial.
EUDRAC has provided substantial amendments for many clients with great success and is aware that inaccurate or non-compliant amendment requests can cause delays in changes to the clinical trial and extra cost of performing the trial.
During marketing authorisation application, the EMA may request the applicant to perform a PASS or DUS when the product is authorised.
Prior to final Opinion on the authorisation of a product, a synopsis of these studies must be submitted to PRAC, and shortly after positive Opinion, a protocol must be submitted to PRAC; for review.
EUDRAC will help clients write the synopsis and protocols for these studies through previous experience of accepted submissions and access to public documentation of on-going and completed studies. We will also facilitate the design and operation of these studies by contacting third-party providers who perform these studies.
The Investigational Medicinal Product Dossier (IMPD) and Investigator’s Brochure (IB) are two documents required for the approval of clinical trials by the competent authorities in the EU.
The IMPD summarises information related to the quality, manufacture and control of any investigational medicinal product (including reference product and placebo), and data from non-clinical and clinical studies.
The Investigator's Brochure (IB) is an active document that summarises information about an investigational medicinal product throughout a clinical trial.
EUDRAC’s medical writing team writes and reviews these documents both prior to applying for and during a clinical trial.
Prior to starting a clinical trial, positive opinion is required from the competent authority and the ethics committee of that territory. Application to the ethics committee is usually performed in parallel to the competent authority.
Alongside the competent authority submission, EUDRAC will also submit applications to the ethics committee.