Nice and the role of scientific advice in shaping access. Requesting scientific advice or protocol assistance from ema. Best practice guidance for pilot ema hta parallel scientific advice procedures. New process for early scientific advice from the ema and hta bodies. Communication with the german agency pei for national scientific advice. 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. At any stage of development of a medicine, scientific advice can be requested from national competent authorities or the ema. 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. Mhra scientific advice briefing document proposed vaccine. Orphan drug designations, scientific advice, briefing meetings. European medicines agency guidance for applicants seeking. The european medicines agency ema can provide medicine developers advice on. Enclosure to the cover letter is the application form.
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. Briefing book for ema qualification procedure actibelt and therefore recommend that the sponsor pursue a formal scientific advice or. Parallel consultation with regulators and health technology. How to successfully navigate through type b and c meetings. Briefing book for ema qualification procedure actibelt and therefore recommend that the sponsor pursue a formal scientific advice or qualification procedure. Guidance on the briefing book for cadth scientific advice 2 november 22, 2016 2. Please see the ema scientific advice website for the latest versions of the briefing document template. Scientific advice is the advice provided by the ema upon the request of companies on the development of a medicine. Scientific advice is about advising medicine developers on the most appropriate. 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. Use the provided template to submit a briefing book bb to nice scientific advice sa in microsoft word format. Scientific advice is also one of the main sources for updating ema scientific guidelines on. Chmp briefing document template standard headings in the template should be used whenever possible.
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. 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. During the evaluation there is at least one facetoface meeting between the applicant and the qualification team. Complying with ema scientific advice is associated with positive maa outcomes 188 maas to ema 2004 2007 analyzed positive outcome. Such consultations may be particularly useful for new active substances or applications that will include complex issues that. It is very important that the briefing document identify the issue in the most concise manner possible and propose a solution. Preclinical trial application cta consultation meeting. The psa program provides scientific advice and protocol assistance in parallel to sponsors.
Health canada invites sponsors to request a precta consultation meeting. This takes four forms standard scientific advice, light scientific advice for small to medium enterprises smes, htaema scientific advice and nicemhra scientific advice. Scientific advice is important for any product to ensure that all regulatory requirements will be met by the final maa. Concerns raised by stakeholders ways to implement the adaptive pathways concept 1 ap report to stamp. Scientific advice and protocol assistance european. A briefing document is a good communication vehicle to keep others abreast of certain issues in a professional manner. 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.
The european medicines agency ema offers consultations in parallel with the. Early dialogue for a medicinal product in clinical development. The briefing book follows a standard format and should include the questions that the sponsor wishes to discuss. 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. Briefing book that consists of background material about the product along with the. Early scientific advice obtained simultaneously from. Chmp protocol assistance scientific advice briefing. In september our team has been involved in six scientific advice procedures covering fda, ema and national agencies in the eu. Hta parallel scientific advice in the european union. Dr jane moseley, scientific administrator, ema scientific advice. Regulatory experience of biomarker qualification in the ema.
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. Early scientific advice obtained simultaneously from regulators and payers. At each briefing series we cover the latest in employment information to keep employers uptodate with the new zealand business scene. 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. 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. This replaces the parallel advice service we delivered with the ema. Chmp protocol assistance scientific advice briefing document. 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. In this context, national hta advice is provided against. Ema hta parallel scientific advice voisin consulting. Replace information in brackets with relevant information on your productcompany. Applicants wishing to apply for scientific advice or protocol assistance from the european medicines agency ema should follow the procedure below. The briefing package contains background information prepared by the food and drug administration fda for the panel members of the advisory committee. 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.
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. Report from the adaptive pathways workshop 8 december 2016. This document, which should be no longer than 50 pages. This will give scientific advice from nice in similar timelines to the european medicines agency ema process. These processes start with an initial discussion on the proposal, followed by the submission of a briefing book. How scientific advice works european medicines agency. 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. We ran this together via the european network for health technology assessment eunethta. The scientific advice is based on background information and questions or issues identified in a briefing book prepared by the applicant. Register yourself or a staff member you think would benefit from attending an ema summer briefing so you. The concurrent scientific advice process works alongside ema timelines and requires submission of the same briefing book provided to the ema. Fda ema parallel scientific advice principles published.
Best practice guidance for the parallel regulatory hta scientific advice procedure ema5026922015 page 532 1. The first draft of the briefing book should be sent to the ema and. Draft best practice guidance for pilot ema hta parallel. 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. Briefing book or briefing materials voisin consulting. 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.
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. Briefing book that consists of background material about the product along with the questions that the manufacturer. 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. Prepare briefing documents and submission of briefing book package. General principles emafda parallel scientific advice human medicinal products the european medicines agency ema and the u. Put yourself into the shoes of regulators while preparing the briefing book as. Participating in scientific advice generates alignment and marks a willingness to communicate with regulators and hta bodies. Scientific advice, protocol assistance, qualification of biomarkers and parallel. Camargo is known for its expertise in the 505b2 pathway. It should contain company questions, justifications or company positions, and appropriate summary information. Prof spiros vamvakas, section head, ema scientific advice.
Dates of 2020 sawp meetings and submission deadlines. Cadth scientific advice is provided verbally at one three 3hour scientific advice meeting. Ema provides scientific advice to support the timely and sound development of highquality, efefctive and safe medicines, for the benefit of patients. The first draft of the briefing book should be sent to the ema and participating htas within 2 weeks of sending in the loi. Best practice guidance for the parallel regulatory hta. Briefing document template standard headings in the template should be used whenever possible. Each scientific advice session lasted for approximately 2 hours and was structured by way of verbal responses from. 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. Scientific advice and protocol assistance european medicines. The effect of patient input on ema scientific advice. Tips for writing a briefing document yourdictionary. European medicines agency ema voisin consulting life sciences.
Liaison with the ema for preparation of numerous scientific advice submissions incl. Validation of briefing book and questions and submission of final briefing book 4. It should be highlighted in the subject heading that the submission concerns a request for scientific or procedural advice. Flutcore universal influenza vaccine active substance.
European health technology assessment and regulatory. 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. Employers and manufacturers association ema northern. State department inspector general requests urgent capitol hill briefing. At day 0, the ed request is submitted to the medicines assessment department of has via a letter of intent. 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. Chmp scientific advice briefing document template standard headings in the template should be used whenever possible.
For the required fee, cadth provides highquality, thoughtfully considered scientific advice that is informed, specific, timely, and fit for purpose. 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. Briefing book guidance for company general points for preparing a briefing book. 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. Looking for some tips for writing a briefing document. Complete a letter of intent using the and prepare a briefing document giving an.
Documentation submitted to facilitate an agency meeting, for example to request scientific advice in relation view definition. Both nice and the ema will assess the briefing book separately and the company will receive two separate list. Guidance on the briefing book for cadth scientific advice. Report from the adaptive pathways workshop 8 december 2016 francesca cerreta ema scientific advice. But, in a global pharmaceutical business, many clients are looking to. The ema scientific advice office r will liaise with 243. The role of integrated scientific advice for the early determination of rwe requirements in hta and payer assessments.