Guidance document Meetings for applicants for authorisation procedures
1 Introduction and purpose
To support companies and in the interest of optimising the authorisation procedure Swissmedic organises meetings for applicants for the mutual exchange of information and to clarify questions relating to content and procedure. This exchange may take place in person, virtually or in writing.
The requirements listed in this Guidance document (WL) ensure that the intended exchange of information, knowledge and experience can be achieved efficiently and productively for both parties.
2 Purpose
This WL is intended for administrative entities and therefore does not establish immediate rights and obligations on the part of individuals. This WL serves primarily as a tool to assist Swissmedic in holding meetings for applicants in a consistent manner, while taking procedural efficiency and availability of resources into consideration. In this WL, Swissmedic makes it clear to applicants and other interested parties what rules and processes it observes in connection with meetings for applicants. The conditions referred to in this WL ensure consistent, transparent and efficient implementation of meetings for applicants.
3 Scope
This WL describes the meeting for applicants for the authorisation procedure, stipulates the documentation to be submitted, the preparation of the exchange (decision on the form of implementation, communication and planning before the meeting, the implementation and subsequent processing of the meeting, and the fee levied.
4 Overview of meetings for applicants
4.1 Meetings at the applicant’s request
Meeting before application submission
LoQ Clarification Meeting with a view to producing a prompt, correct and complete response to the List of Questions (LoQ), particularly if major objections exist.
Preliminary Decision Clarification Meeting for human medicinal products
Meetings with applicants may also be held as part of applications for the fast-track authorisation procedure for human medicinal products or applications for temporary authorisation; the corresponding requirements are listed in the Guidance document Fast-track authorisation procedure, the Guidance document Temporary authorisation procedure for human medicinal products or the Guidance document Temporary authorisation of veterinary medicinal products.
4.2 Meeting initiated by Swissmedic
▪ Labelling Meeting to clarify remaining individual aspects of labelling following a preliminary decision.
5 Description
5.1 Meetings at the applicant’s request
5.1.1 Meeting before application submission
Companies may request a Meeting before application submission with Swissmedic at any phase of development of a medicinal product. The meeting enables early exchange between the companies and Swissmedic. The Meeting before application submission should help to clarify questions relating to content and procedure with Swissmedic. Mutual sharing of scientific information is also possible. The following topics for discussion are possible at a Meeting before application submission:
Dialogue on international developments As part of the dialogue, companies have the opportunity to inform Swissmedic on the current status of discussions with foreign authorities and exchange information on this with Swissmedic. It is also possible to get a second opinion on scientific advice received from foreign authorities..
Information on pipeline / planned applications Companies can discuss their product pipeline with Swissmedic during the Meeting before application submission. The focus is on future new applications and their extensions in the advanced stage of development. The exchange primarily serves to inform Swissmedic regarding the intention to submit within the coming 1 to 3 years.
Clarification of technical questions (regulatory, quality, preclinical, clinical, vigilance) Questions concerning the development of a medicinal product can be resolved. These may be questions on the quality of active pharmaceutical ingredients and the manufacture of pharmaceutical products, for example, on the planning and organisation of preclinical investigations and clinical trials, and on aspects of pharmacovigilance and the risk management plan. The information provided by Swissmedic during a Meeting before application submission does not pre-empt the evaluation of the content of the documentation associated with applications for authorisation. It is also possible to clarify questions regarding document finalisation for an authorisation application. In general these questions relate to administrative, regulatory and legal issues surrounding the submission of the application which have not already been clarified by legislation, guidance documents, publications in the Swissmedic Journal or other relevant, publicly available documents. The Meeting before application submission is not linked to a specific future authorisation application
and is valid for all procedures. It is possible to address a combination of discussion topics.
5.1.2 LoQ Clarification Meeting
LoQ Clarification Meetings enable the applicant, in justified cases, to clarify specific issues arising from the LoQ with Swissmedic. Since Swissmedic has already provided the applicant with the annotated Information for healthcare professionals texts with the LoQ, the meetings can also be used to resolve comprehension issues connected with labelling. The following points can be clarified:
Discussion and explanation of questions arising from the LoQ, incl. on labelling, where these have not been clearly understood by the applicant.
Clarification of questions regarding the applicant’s intended response strategy, for example ➢ Discussing a proposal on the strategy for a restriction of the indication (based on the study data available at the time of initial submission) ➢ Discussing a different strategy for the re-analysis required by Swissmedic To ensure efficiency, the applicant can table concepts and proposals prior to the meeting. The data required by Swissmedic should be submitted with the reply to the LoQ. No new data are accepted during the LoQ Clarification Meeting. Nor is the content of the data required with the LoQ reviewed. The meeting cannot pre-empt the results of the review or the decision on review phase II. The LoQ Clarification Meeting is designed to simplify the process of preparing responses to the LoQ in particular if there are “Major Objections”). At the same time, this approach should allow the Swissmedic Case Team – proactively and with an eye to the duration of the procedure – to ensure the best possible assessment of the intended answers.
5.1.3 Preliminary Decision Clarification Meeting for human medicinal products
A Preliminary Decision Clarification Meeting can be requested for applications for new authorisation of human medicinal products with new active substance (NAS) and their additional indications. It is irrelevant which procedure (standard procedure, FTP, temporary authorisation, PPN, Access Work Sharing if Swissmedic is the lead reviewer of Module 5, Project Orbis) is used for the application in question. When submitting a request for a Preliminary Decision Clarification Meeting, the applicant must provide Swissmedic with justification of the purpose of the meeting. In principle, the following are possible:
The applicant has comprehension questions regarding the objections communicated by Swissmedic in the preliminary decision and would like to clarify the unclear points in a constructive scientific dialogue and acquire an in-depth understanding1.
The applicant would like an assessment of the intended response strategy. In this case, the applicant should submit a clear proposal which Swissmedic can then comment on during the meeting. The following will not be considered:
A repetition or renewed oral presentation of previously stated positions and arguments from the previous review process.
Discussions of deviating decisions by foreign authorities. The intended decision is based on Swissmedic's review results.
Newly submitted data since no assessment of the content of new aspects takes place at this time.
In connection with applications subject to international procedures, discussion points concerning aspects that still need to be discussed with partner authorities.
1 For example, questions regarding implementation of the requirements and/or conditions given in the preliminary decision,
unclear points in the PD, or on the modification of the information for healthcare professionals (e.g. warnings / ADRs).
The individual points for discussion requested by the applicant must be listed and justified in the request for a meeting. The objective is mutual scientific dialogue. The assessment of the planned written response to the preliminary decision and the final decision cannot be anticipated during the meeting. For questions regarding a possible resubmission in the case of a negative authorisation decision, or if the applicant decides to withdraw the application, Swissmedic offers appropriate company meetings after the decision has been issued, which can be requested shortly after the decision.
5.2 Meeting initiated by Swissmedic
5.2.1 Labelling Meeting
Unlike the meetings described above, Labelling Meetings are initiated exclusively by Swissmedic. After the answers to the preliminary decision have been reviewed, any remaining open individual aspects in the medicinal product information (labelling) are clarified in a discussion with the applicant. The Labelling Meeting is an additional vessel for informal exchange and for the text review letters.The Labelling Meeting is designed to avoid additional text review rounds and enable the review process to be concluded efficiently.
6 Formal aspects and structure of the meeting for applicants
The general formal requirements are specified in the Guidance document Formal requirements and the accompanying Directory Overview of documents to be submitted. Requests to hold a company meeting must be submitted in writing. The applicant should justify their request for a meeting in a cover letter.
6.1 Documents to be submitted
6.1.1 Meeting before application submission
The following information or documents must be submitted:
Contact address in Switzerland
Draft agenda with details of the topics/points to be discussed
Form Meetings for applicants for authorisation procedures
List of issues, if applicable: Presentation of the issues to be clarified during the meeting, usually in the form of a Briefing Book
Proposal for the style of the meeting: face to face on Swissmedic’s premises, teleconference, video conference or written response
Proposed dates (between four and eight weeks after the application for a meeting is submitted)
Presentation slides (at least 1 week before the meeting)
6.1.2 LoQ Clarification Meeting
The following information or documents must be submitted: ▪ Form Meetings for applicants for authorisation procedures incl. list of issues with the applicant’s concepts and proposals (the clearly defined and justified opinion). Objective: scientific dialogue
Draft agenda with the points to be discussed
Proposal for the style of the meeting: face to face on Swissmedic’s premises, teleconference, video conference or written response
Proposed dates for the discussion (within approx. three weeks of receipt of the request)
The meeting request must be submitted within four weeks of receipt of the LoQ.
Presentation slides (at least 1 week before the meeting)
6.1.3 Preliminary Decision Clarification Meeting for human medicinal products
The following information or documents must be submitted:
Form Meetings for applicants for authorisation procedures incl. list of issues and briefing documents and, if applicable, proposal for the applicant's intended response strategy
Rationale for holding the Preliminary Decision Clarification Meeting incl. meeting objective. Objective: scientific dialogue
Draft agenda with the points to be discussed
Proposal for the style of the meeting: face to face on Swissmedic’s premises, teleconference, video conference or written response
Proposed dates for the meeting (within approx. three weeks of receipt of the request)
The meeting request must be submitted within two weeks of receipt of the preliminary decision
Presentation slides (at least 1 week before the meeting)
6.1.4 Labelling Meeting
The Labelling Meeting is scheduled exclusively by Swissmedic. Swissmedic informs the applicant in writing of the points to be clarified.
The applicant informs Swissmedic within 5 days of the type of interaction (virtual meeting or written reply).
If the interaction is to take place as a teleconference, the applicant suggests possible meeting dates (within 5 to 10 days after the announcement of the type of interaction).
If the applicant prefers a written interaction, the replies concerning the points to be clarified should be submitted to Swissmedic within max. 10 days.
6.2 Requirements
The documentation must meet the following requirements:
The documents submitted must be ordered so that they correspond to the subject areas set out in the form Meetings for applicants for authorisation procedures.
The topics to be discussed must be listed for the scientific dialogue.
The questions must be formulated clearly and in detail.
For LoQ Clarification Meetings, the documents should include the applicant’s views and proposals, together with the applicant’s clearly defined and justified opinion.
If the applicant would like an assessment of the intended strategy for responding to the preliminary decision issued by Swissmedic, a clear proposal for the applicant's intended response strategy should be submitted with the request for the Preliminary Decision Clarification Meeting.
Only those topics listed in the agenda or stated in the list of issues will be discussed at the meeting. If questions cannot be answered conclusively during the meeting, Swissmedic will provide its written opinion following the meeting. If the situation changes significantly between the submission and the anticipated date of the meeting, the applicant should inform the responsible Regulatory Manager immediately and clarify the subsequent steps to be taken. A revised list of issues may result in the date of the meeting being pushed back. The documentation submitted should provide Swissmedic’s experts with the necessary background information. The information should refer directly to the topics to be discussed and the issues raised. The scope should reflect the issues raised, be short and concise, and be designed to facilitate efficient processing by Swissmedic.
6.3 Duration of the meeting
The duration of the meeting depends on the number and scope of the topics / questions. Meetings upon company request usually last a maximum of 90 minutes. The duration of the Preliminary Decision Clarification Meeting is limited to max. 60 minutes. The Labelling Meeting usually lasts from 30 minutes to max. 60 minutes.
6.4 Preparation of the meeting
6.4.1 Examination of the application for the meeting
The request is generally assessed within two to four weeks, or within one to two weeks in the case of the LoQ Clarification Meeting and the Preliminary Decision Clarification Meeting. Swissmedic reserves the right not to agree to hold a meeting or discuss individual points for discussion. Once the review has been completed, Swissmedic confirms the meeting date to the company. Swissmedic reserves the right to respond to questions in writing in exceptional cases.
6.4.2 Meeting dates/participants
Swissmedic determines the date of meetings taking into account the availability of the experts from the Divisions concerned. Meetings for applicants are usually held four to eight weeks following receipt of the formally correct request. LoQ Clarification Meetings and Preliminary Decision Clarification Meetings are held approx. three weeks after receipt of the request for the meeting. In the interests of ensuring effective discussion, the delegations from Swissmedic and the applicant must consist of competent experts and remain as small as possible in number. The participation of Key Opinion Leaders should be avoided.
6.5 Structure of the meeting
Swissmedic will chair the meeting. The agenda follows the topics/list of issues. The meetings usually proceed as follows:
1 Welcome and brief introduction of participants
2 Presentation by the applicant of the topics/issues raised, including a short overview of the key
facts and background
3 Potential brief opinion by Swissmedic’s expert representatives
4 Discussion
5 Closure of the meeting with summary and identification of the next steps
The applicant will draft the minutes of the meeting in one of Switzerland’s official languages or in English in the template provided by Swissmedic (see form Company meeting record). This document must summarise the conclusions of the meeting in a brief and precise manner and include the following information:
Date and duration of the meeting
Brand name (if available) and description of the active pharmaceutical ingredient(s) (INN) of the medicinal product concerned
Name and function of participants
Summary of the opinion of the applicant and that of Swissmedic
Next steps The applicant should send the draft minutes to the Swissmedic Regulatory Manager in Word format via the Portal or e-mail by two weeks after the meeting at the latest. Swissmedic will examine the minutes, usually within two weeks, modify them as necessary, and return them to the applicant. The minutes are to be based on the current status of knowledge at the time of the meeting. Swissmedic may take subsequent recent developments into consideration when issuing its authorisation decision.
7 Fees
Swissmedic will invoice the applicant for the costs related to the meeting, based on the administrative and scientific resources involved. The fees are in accordance with the Ordinance on Fees Levied by the Swiss Agency for Therapeutic Products (FeeO-Swissmedic; SR 812.214.5). The costs for the Labelling Meeting are covered by the respective flat fees charged for the authorisation procedure. Swissmedic will waive any fee (Art. 12 FeeO-Swissmedic) for holding Meetings before application submission for applications for authorisation of vital medicines according to Annex 1 of the Ordinance on the Essential Human Medicines Reporting Office (SR 531.215.32).
8 Annex 1 – Flow diagram
Before submission of application for authorisation
Request for meeting submitted Meeting before Application Submission Review by
Before application submission – wks after
receipt
Decision on go-ahead
Agreement on style of
the meeting
Communication of meeting date and
participants
– wks • • after receipt Meeting before Application Submission
Legend:
Milestone / activity by applicant
Milestone / activity by Swissmedic
After submission of After submission of application for application for authorisation authorisation
Receipt of application Receipt of application
List of Questions Preliminary decision
Up to 4 Up to 2 wks wks Request for meeting Request for meeting submitted submitted Preliminary LoQ Clarification Decision Clarification Review by Review by Meeting Meeting 1-2 wks – wks after after
Swissmedic Swissmedic receipt receipt
Authorisation process Authorisation process Decision on go-ahead Decision on go-ahead
Agreement on style of Agreement on style of the meeting meeting Communication of Communication of meeting date and meeting date and participants participants approx. 3 approx. 3 wks after • • wks after • • receipt receipt LoQ Clarification Preliminary Meeting Decision Clarification Meeting
Official decision Official decision
Legend:
Milestone / activity by applicant
Milestone / activity by Swissmedic
After submission of application for authorisation
Receipt of application
Reply to preliminary decision
SMC contacts the applicant
Authorisation process within 5 days
Applicant informs SMC of the type of interaction (TC or written reply)
– days
Labelling Meeting (if applic. written reply)
Official decision
Change history Version Change sig
5.0 Definitive introduction of Preliminary Decision Clarification Meeting for human fg, zsa, hcr, pfc, rc
medicinal products
4.0 Introduction of new Meeting before application submission fg, zsa, hcr, pfc, rc
Clarification of Pilot Preliminary Decision Clarification Meeting
3.0 Clarifications regarding company meetings. Description of pilot Preliminary fg, ble, zsa, pfc, rc
Decision Clarification Meeting.