Early dialogue for a medicinal product in clinical development. General principles emafda parallel scientific advice human medicinal products the european medicines agency ema and the u. In the context of preparedness for the uks withdrawal from the european union eu, ema advises ukbased micro, small and mediumsized enterprises smes to note the deadlines published on the brexitrelated guidance for companies webpage regarding the date of uks withdrawal from the eu when applying for scientific advice and protocol assistance in order to. Chmp scientific advice briefing document template standard headings in the template should be used whenever possible.
It is very important that the briefing document identify the issue in the most concise manner possible and propose a solution. Briefing book or briefing materials voisin consulting. Health canada invites sponsors to request a precta consultation meeting. Scientific advice is also one of the main sources for updating ema scientific guidelines on. The european medicines agency ema has published today a report on its pilot on parallel scientific advice with healthtechnologyassessment hta bodies that finished at the end of march 2016.
Parallel consultation with regulators and health technology. Preind and scientific advice meetings by the time a typical virtual biotech company is close to first in human studies there is often a web of data generated over years often at many cros. The european medicines agency ema offers consultations in parallel with the. Briefing book for ema qualification procedure actibelt and therefore recommend that the sponsor pursue a formal scientific advice or qualification procedure. Concerns raised by stakeholders ways to implement the adaptive pathways concept 1 ap report to stamp. Best practice guidance for pilot ema hta parallel scientific advice procedures. We ran this together via the european network for health technology assessment eunethta. Orphan drug designations, scientific advice, briefing meetings. The briefing book follows a standard format and should include the questions that the sponsor wishes to discuss. Complete a letter of intent using the and prepare a briefing document giving an. Draft best practice guidance for pilot ema hta parallel. This takes four forms standard scientific advice, light scientific advice for small to medium enterprises smes, htaema scientific advice and nicemhra scientific advice.
Guidance on the briefing book for cadth scientific advice 2 november 22, 2016 2. Employers and manufacturers association ema northern. The european medicines agency ema can provide medicine developers advice on the most appropriate way to generate robust evidence on a medicines benefits and risks. Such consultations may be particularly useful for new active substances or applications that will include complex issues that.
Our consultancy has found that great value can be added when your body of data is organized in a format consistent with the requirements for your. Briefing book guidance for company general points for preparing a briefing book. Nice and the role of scientific advice in shaping access. Each scientific advice session lasted for approximately 2 hours and was structured by way of verbal responses from. Scientific advice and protocol assistance european medicines. Briefing book for ema qualification procedure actibelt and therefore recommend that the sponsor pursue a formal scientific advice or. Submitting a request complete a letter of intent using the and prepare a briefing document giving an introduction to the medicine under development, and the companys questions and positions.
A briefing document is a good communication vehicle to keep others abreast of certain issues in a professional manner. Fda ema parallel scientific advice principles published. For the required fee, cadth provides highquality, thoughtfully considered scientific advice that is informed, specific, timely, and fit for purpose. Communication with the german agency pei for national scientific advice. The first draft of the briefing book should be sent to the ema and participating htas within 2 weeks of sending in the loi. Requesting scientific advice or protocol assistance from ema. In september our team has been involved in six scientific advice procedures covering fda, ema and national agencies in the eu. Report from the adaptive pathways workshop 8 december 2016. Replace information in brackets with relevant information on your productcompany. A parallel scientific advice emahta sa is a pilot project including the ema and selected national health technology assessment bodies allowing the applicant to obtain a joint advise on its development plan and price and reimbursement strategy.
In this article we give some handson advice on how to successfully navigate through type b and c meetings with fda based on our recent experience with fda. It should be highlighted in the subject heading that the submission concerns a request for scientific or procedural advice. European health technology assessment and regulatory. The european medicines agency ema can provide medicine developers advice on. Complying with ema scientific advice is associated with positive maa outcomes 188 maas to ema 2004 2007 analyzed positive outcome. European medicines agency guidance for applicants seeking. Scientific advice, protocol assistance, qualification of biomarkers and parallel. At each briefing series we cover the latest in employment information to keep employers uptodate with the new zealand business scene. This replaces the parallel advice service we delivered with the ema. Report from the adaptive pathways workshop 8 december 2016 francesca cerreta ema scientific advice. Dr jane moseley, scientific administrator, ema scientific advice. Use the provided template to submit a briefing book bb to nice scientific advice sa in microsoft word format. Liaison with the ema for preparation of numerous scientific advice submissions incl.
During the evaluation there is at least one facetoface meeting between the applicant and the qualification team. Looking for some tips for writing a briefing document. Briefing document template standard headings in the template should be used whenever possible. Scientific advice and protocol assistance european. It should contain company questions, justifications or company positions, and appropriate summary information. The concurrent scientific advice process works alongside ema timelines and requires submission of the same briefing book provided to the ema. The psa program provides scientific advice and protocol assistance in parallel to sponsors. How scientific advice works european medicines agency. Food and drug administration fda and european medicines agency ema recently released an updated general principles statement regarding the agencies parallel scientific advice psa program for human medical products. The procedure to provide this broad scientific advice is based on the existing scientific advice procedure but is adapted to host the activity of the qualification team and to incorporate international collaboration. Ema and htabs ema provides advice from regulators pertaining to the conduct of the various tests and trials that are needed to demonstrate the quality, safety and ef ficacy of medicinal products. Regulatory experience of biomarker qualification in the ema. Dates of 2020 sawp meetings and submission deadlines. Hta parallel scientific advice in the european union.
Early scientific advice obtained simultaneously from regulators and payers. Validation of briefing book and questions and submission of final briefing book 4. Tips for writing a briefing document yourdictionary. But, in a global pharmaceutical business, many clients are looking to. Flutcore universal influenza vaccine active substance. At any stage of development of a medicine, scientific advice can be requested from national competent authorities or the ema. Best practice guidance for the parallel regulatory hta. Best practice guidance for pharmaceutical companies for submission and proceeding of an early dialogue at the national level with has or at the european level with ema andor other hta bodies march 2017 medical, economic and public health assessment division. This document, which should be no longer than 50 pages. The ema scientific advice office r will liaise with 243. State department inspector general requests urgent capitol hill briefing.
Best practice guidance for the parallel regulatory hta scientific advice procedure ema5026922015 page 532 1. Following a briefing phase, the pilot scientific advice meetings for both compounds took place at the offices of the tga in canberra in may 2009. Cadth scientific advice is provided verbally at one three 3hour scientific advice meeting. Please see the ema scientific advice website for the latest versions of the briefing document template. The first draft of the briefing book should be sent to the ema and. Scientific advice is important for any product to ensure that all regulatory requirements will be met by the final maa. The briefing book is the reference document containing all the information and questions used within the joint psa process seeking early scientific advice from eu payers 12. Put yourself into the shoes of regulators while preparing the briefing book as. Ema hta parallel scientific advice voisin consulting. Participating in scientific advice generates alignment and marks a willingness to communicate with regulators and hta bodies.
This letter word document includes the brand name and the international common denomination of the drug, the claimed indication be precised, for example state the line of. The briefing package contains background information prepared by the food and drug administration fda for the panel members of the advisory committee. In order to have continuous successful development, we are following the recommendation of the itf from 17 november 2016 to request an ema qualification procedure with the goal of. Enclosure to the cover letter is the application form. New process for early scientific advice from the ema and hta bodies.
Parallel scientific advice with the ema and fda may lead to an increased dialogue between the two agencies and sponsors from the beginning of the lifecycle of a new product, a. Scientific advice is about advising medicine developers on the most appropriate. The effect of patient input on ema scientific advice. Briefing book that consists of background material about the product along with the questions that the manufacturer. Register yourself or a staff member you think would benefit from attending an ema summer briefing so you. Documentation submitted to facilitate an agency meeting, for example to request scientific advice in relation view definition. Applicants wishing to apply for scientific advice or protocol assistance from the european medicines agency ema should follow the procedure below. Emahta parallel consultation new process for early scientific advice from the ema and hta bodies the european medicines agency ema has replaced the emahta parallel scientific advice procedure with a new. European medicines agency guidance for applicants seeking scientific advice and protocol assistance ema 42602001 page 423 it is the sawpchmp responsibility to give scientific advice to industry by answering to questions. In this context, national hta advice is provided against. Guidance on the briefing book for cadth scientific advice. Although scientific advice is not a requirement for approval, it is important to note that maa approval rates are much high for companies who seek the agencys advice and follow it. Prof spiros vamvakas, section head, ema scientific advice.
European medicines agency ema voisin consulting life sciences. Chmp protocol assistance scientific advice briefing. Ema provides scientific advice to support the timely and sound development of highquality, efefctive and safe medicines, for the benefit of patients. Early scientific advice obtained simultaneously from.
Camargo is known for its expertise in the 505b2 pathway. A potential to vet your briefing book generate interest in becoming rapporteur ema scientific advice working party sawp potential input from other scientific committees, e. Scientific advice is the advice provided by the ema upon the request of companies on the development of a medicine. How to successfully navigate through type b and c meetings. Briefing book or briefing materials documentation submitted to facilitate an agency meeting, for example to request scientific advice in relation to a proposed drug development pathway. Health authority briefing documents also known as briefing packs, briefing packages, and briefing books are documents prepared by a pharmaceutical company to support its interactions e. Both nice and the ema will assess the briefing book separately and the company will receive two separate list. This will give scientific advice from nice in similar timelines to the european medicines agency ema process. Prevention of disease caused by influenza a virus the intention is to expand the vaccine and the indication to.
The scientific advice is based on background information and questions or issues identified in a briefing book prepared by the applicant. Mhra scientific advice briefing document proposed vaccine. At day 0, the ed request is submitted to the medicines assessment department of has via a letter of intent. Preclinical trial application cta consultation meeting. Scientific advice and protocol assistance the special form of scientific advice available for the development of medicines for orphan or rare diseases can be provided by the european medicines agency to pharmaceutical companies on request and can be a vital contribution to the regulatory affairs process. The role of integrated scientific advice for the early determination of rwe requirements in hta and payer assessments. Briefing book that consists of background material about the product along with the.