This post is an attempt to provide basic information on the Swissmedic Marketing Authorisation for Global Health Products (MAGHP) and the MAGHP Light procedures.
The MAGHP and MAGHP Light Procedures are part of Swissmedic’s engagement in development cooperation, in accordance with its strategic objectives for 2019-2022. In line with these objectives, Swissmedic is committed to improving access to therapeutic products by strengthening regulatory systems in low- and middle-income countries (LMICs), with a focus on countries in sub-Saharan Africa.
The aim of the Marketing Authorisation for Global Health Products (MAGHP) programme is to make Swissmedic’s authorisation procedure accessible to regulatory authorities in low and middle-income countries (LMICs).
In order to understand the detail of both procedures, please refer to the information resources (via the links provided) in the post.
In January 2014, a Memorandum of Understanding (MoU) was signed between the following parties:
- the Bill & Melinda Gates Foundation
- the Swiss Federal Department of Foreign Affairs and
- the Federal Department of Home Affairs.
Along with the amended mandate that was approved by the Federal Council in
September 2013, this MoU provides the basis for the involvement of Swissmedic in projects in the area of development cooperation.
- The overall goal of this partnership is to accelerate and increase access to high-quality, essential medicines for populations living in low- and middle-income countries (LMICs), focussing on countries in sub-Saharan Africa.
- This is to be achieved by leveraging and coordinating resources through cooperation between the three parties to the MoU and the WHO.
- The aim is to increase the efficiency of the regulatory review and registration process by focusing stakeholders on value-added activities, and to strengthen the regulatory authorities’ ability to protect their citizens’ health via capacity building.
Source: Swissmedic
The cooperation focuses on improving and accelerating access to essential therapeutic
products in resource constrained countries by strengthening the regulatory systems. The following three projects have been developed and are being implemented. The Marketing Authorisation for Global Health Products (MAGHP) is one component of this cooperation.
Project No 1 (since 2015)
To support to the implementation of the African Medicines Regulatory Harmonisation (AMRH) programme. The AMRH Programme, a collaborative effort of a consortium of partners, supports African countries and regions in building effective regulatory networks for medicines inside established Regional Economic Communities (RECs) in order to improve access to essential medicines.
Project No 2 (since 2015)
To make the Swissmedic procedure for scientific advice and the procedure for Marketing Authorisation for Global Health Products (MAGHP) accessible to:
- representatives of the regulatory authorities in countries with low and middle income (LMICs)
- the World Health Organisation (WHO)
Project No 3 (since 2018)
Capacity building trainings/activities for foreign National Regulatory Authorities (NRAs) i.e. Regulatory Training, Swissmedic GMP Training, Guided Inspections.
Source: Swissmedic
Although participation of other regions may be considered, the focus is on supporting regulators in the sub-Saharan region of Africa with the goal of accelerating access to medicinal products – mainly, but not exclusively, for those diseases that disproportionately affect the region.
In the context of the MAGHP, this should be achieved by involving the National Regulatory Authorities (NRAs) of the countries concerned.
In order to guarantee an optimal exchange, Swissmedic envisages a maximum number of approximately 10 countries.
The procedure consists of two independent components:
- Scientific advice – To clarify scientific questions in the development phase of a planned submission
- Marketing authorisation –
- The procedure follows the regular Swissmedic marketing authorisation procedure (same timeframes, procedural steps and evaluation criteria) with the difference being that concerned National Regulatory Authorities (NRAs) and the World Health Organisation (WHO) are involved.
MA for Switzerland or so called export registration
The MAGHP procedure builds on the existing authorisation processes at Swissmedic.
- In case of an approval, the procedure results in a marketing authorisation for Switzerland or a so called export registration (see below).
- Therefore, those criteria that are applicable to the assessment and significant for decision-making purposes refer to the medical situation and regulatory requirements in Switzerland.
- The marketing authorisation can be requested for Switzerland or as a so-called export registration, which allows the product to be marketed only outside Switzerland. However, the requirements in terms of the necessary data and documentation, as well as the review process, are the same for both types of marketing authorisation.
What happens to inputs and comments received from participating National Regulatory Authorities (NRAs)?
The inputs and comments received from participating National Regulatory Authorities (NRAs) are taken into consideration and are included in the exchange with the applicant. These inputs may address country-specific issues, such as:
- special requirements regarding stability data (e.g. climate zone 4),
- risk management plan
- disease programmes, including country-specific treatment guidelines, and will serve as important information for the applicant with regard to the dossier submission.
The requirement for a Swiss MA Holder
For all applications, including those for export only, a Swiss marketing authorisation holder is required. However, an applicant does not necessarily need to be based in Switzerland, but can work through a representative, e.g. a regulatory office.
The MAGHP and timelines
- The MAGHP procedure and its timelines follow the regular marketing authorisation procedure at Swissmedic.
- In addition, applicants are requested to submit a prior notification around three to six months before the planned submission date in order to allow proper planning of resources and involvement of NRAs.
Participation of the NRAs and local submission of dossier
The National Regulatory Authorities (NRAs) are invited to participate actively in the assessment, with the aim of building their own capacities and establishing confidence in the process. It is expected that the timelines for the marketing authorisation by NRAs will be significantly reduced, making essential medicines available for patients faster.
It is important to note that in addition to the application to Swissmedic:
- The individual dossier will also need to be submitted according to the national requirements to each targeted NRA.
- Apart from national specifics, the dossier must be essentially the same.
- The applicant is encouraged to submit the dossier as early as possible in the process.
The MAGHP is performed in collaboration with WHO.
- WHO facilitates the first contact between Swissmedic and the target NRAs and the nomination of experts.
- If indicated and requested, experts from WHO provide scientific expertise on programmatic aspects.
- The WHO closely follows the process of the MAGHP procedure.
- Upon request by the applicant for prequalification, as well as for the WHO collaborative procedure, the assessment report generated by Swissmedic under the MAGHP procedure is shared with WHO prequalification and the national regulatory authorities participating in the WHO collaborative procedure to facilitate their regulatory decisions.
The objective of a scientific advice meeting during the development phase is:
- to respond to specific questions on the quality of active pharmaceutical ingredients and pharmaceutical products,
- on the planning and organisation of preclinical investigations and clinical trials, and
- on aspects of pharmacovigilance and the risk management plan.
If questions cannot be answered conclusively during the meeting, Swissmedic will provide its written opinion following the meeting.
The applicant submits a request for a scientific advice meeting for a medicinal product falling under the MAGHP procedure to Swissmedic, Case Management (CM) Division. The request includes specific information and documents.
- Swissmedic Stakeholder Engagement (SHE) Division initially contacts the National Regulatory Authorities (NRAs) listed in the request as well as WHO to obtain their feedback, if they are interested in actively participating in the scientific advice meeting.
- This would include access to the documentation on a secure electronic platform as well as nomination of reviewers/experts to be involved in the meeting and/or provision of (scientific) input.
- NRAs confirming their interest in active participation will be referred to as “NRAs concerned”.
- Feedback from NRAs and WHO shall be sent to the SHE Division at Swissmedic.
In the context of scientific advice concerning a medicinal product intended for submission under the MAGHP procedure, the World Health Organisation (WHO) and NRAs concerned may contribute their opinion and (specific) requirements.
| Participant | Role(s) |
|---|---|
| Swissmedic | Swissmedic leads the evaluation of the application and is responsible for: · timelines · List of Questions (LoQ) and Decision sent by day 330. Swissmedic makes an independent risk-benefit evaluation but takes into consideration the comments of the NRA’s and WHO’s experts. All their relevant concerns are integrated in the exchange with the applicant. |
| WHO | WHO facilitates the first contact, in particular, between Swissmedic and the target NRAs. If indicated, WHO experts (e.g. on disease programmes / Prequalification Team) are consulted to provide scientific expertise on programmatic aspects. Upon request by the applicant for prequalification, as well as for the WHO collaborative procedure, the assessment report generated by Swissmedic under the MAGHP procedure is shared with WHO prequalification and the national regulatory authorities participating in the WHO collaborative procedure to facilitate their regulatory decisions. |
| National Regulatory Authorities (NRAs) | The NRA: · evaluates the dossier submitted by the applicant and Swissmedic’s assessment reports (incl. LoQ). · writes an assessment report (if possible) reflecting the medical need and regulatory requirements in their country. · comments on Swissmedic’s assessment reports, risk benefit evaluation, preliminary decision, SmPC and PIL and adds its own questions to the LoQ. · country-specific documents, such as risk management plans, must be evaluated by the respective NRAs. Provided the dossier has been submitted, the NRAs concerned commit to decide on an authorisation within 90 calendar days after completion of the procedure at Swissmedic. If the dossier has not been submitted by the end of the Swissmedic procedure, the decision must be made within 90 calendar days after dossier receipt. |
| Applicant | The applicant: · submits the dossier to Swissmedic and conducts dialogue related to the dossier processing · specifies the NRAs to be involved · signals the need to include the WHO. · The dossier is submitted to each individual NRA concerned as early in the process as possible. · Modules 2 to 5 must be identical to the version submitted to Swissmedic. · During the MAGHP process the applicant has the option of switching to the standard Swissmedic processes without the involvement of the NRAs concerned. |
The NRAs and the WHO are involved in the process as follows:
- Get access to information
- Full documentation as submitted by the applicant (product dossier)
- Swissmedic assessment reports and List of Questions (LoQ)
- Provide input
- Evaluating/writing assessment reports
- Adding questions to LoQ
- Participate in meetings
- Scientific advice/pre-submission meeting
- Case team meetings*
- Experts review board*
*Internal meetings at Swissmedic
Source: Slide no 12 ( presented at a virtual event in March 2021 on the MAGHP procedure entitled A contribution to accelerating access to quality medical products in low and middle-income countries).
The NRAs involved in the MAGHP will benefit from being part of the Swissmedic evaluation procedure. This will enable them to:
- acquire knowledge about the product,
- gain confidence in the scientific evaluation at Swissmedic and at the same time, provide their own inputs and comments on the evaluation.
Therefore, the expectation is that the authorisation procedure can be shortened for the NRAs because:
- knowledge about the product has already been acquired (“well-informed” reliance),
- access to the Swissmedic assessment and inspection reports is granted and
- confidence in the scientific process at Swissmedic has been gained.
Currently, the lifecycle management of products that have been approved using the MAGHP procedure only affects the Swiss market. As soon as more experience has been gained with the procedure, an extension of the scope will be considered. Nevertheless, it is important to note that the responsibility for the product remains with the NRAs in their respective markets.
The conditions of eligibility are:
1) That the authorisation application must concern one of the following:
- a medicinal product with a new active pharmaceutical ingredient (new API)
- a medicinal product with a known active pharmaceutical ingredient (known API) or
- a new indication for a medicinal product with a new or a known API.
2) The clinical and preclinical trials must be completed at the time of application submission
3) Any results from partner authorities’ assessments available to the applicant, particularly assessment reports from the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA) must be included in the submission.
Prior notification and processing of the prior notification
If the applicant is informed that an MAGHP procedure is possible within the proposed timeframe, the applicant shall:
- submit a written prior notification to Swissmedic at the latest three months before the planned submission date
- confirm in the notification, the date on which the application will be submitted as well as the date of the pre-submission meeting.
In parallel the applicant shall inform the NRAs concerned about the intended dossier submission. This information is important for the planning and resource allocation at the NRAs.
Pre-submission meeting
The primary aim of the pre-submission meeting (approx. six weeks prior to the submission) is to clarify whether all the documentation required to process the application is available. In particular, this concerns the folllowing aspects of the application to be submitted:
- Index of the scientific documentation and the administrative documents
- Any open questions regarding the documentation
- Information on manufacturers concerned
- Date of submission of the eCTD test sequence (if an eCTD application is to be submitted)
- Volume of the submission
- Establishing the final submission date and the timelines for the marketing authorisation procedure
- Planning of sample testing, if applicable
Processing the application for authorisation
The processing timeline and brief details of the steps involved is provided in the table below.
Communication until day 330 (decision) during the MAGHP procedure takes place between the applicant and Swissmedic.
Communication in the National Regulatory Authority (NRA) national decision phase takes place between the NRAs concerned and the applicant directly. On request, Swissmedic facilitates the contact between the applicant and the NRAs concerned.
| Day | Phase | Steps |
|---|---|---|
| Day 0 | Submission | Submission of initial MA application to Swissmedic |
| Day 1-30 (30 days) | Validation pf the initial application | Validation decision made and communicated to applicant within 30 days of the submission. If the formal requirements are fulfilled, the application is accepted and the applicant is informed accordingly. In case of deficiencies, applicant is granted a 60 day period in which to remedy the deficiencies. If not remedied within the given timeframe, Swissmedic will reject the application. |
| Days 31 -150 (120 days) | Evaluation Assessment Phase I | The documentation is reviewed by the case manager (regulatory) and quality, preclinical and clinical reviewers. Each will prepare an LoQ, resulting in four parts of an assessment report. A kick-off meeting with the NRA’s representatives and Swissmedic’s reviewers is held to introduce the dossier and discuss any potential challenges to the review. Next, the NRA’s experts are invited to study the dossier submitted by the company, write their own assessment report and form their opinion about the application. Swissmedic shares the preliminary assessment reports with the NRAs concerned a case team meeting is held to present the outcome of Swissmedic’s review. Subsequently, the NRA’s experts are expected to study and comment on the Swissmedic assessment reports (incl. the drafted LoQ) and to add their own questions. These inputs provided by the NRAs should address country-specific issues, such as special requirements regarding stability data (e.g. climate zone 4), risk management plan or disease programmes, including country-specific treatment guidelines, and will serve as important information for the applicant with regard to the dossier submission. |
| Day 150 | List of Questions (LoQ) | List of Questions (LoQ) sent to the applicant on Day 150. The applicant has 90 days to respond to the LoQ. The applicant may ask for an extension of this period by a maximum of a further 90 days. Within 2 weeks of receipt of the LoQ, the applicant shall inform Swissmedic of the planned date of submission of its response to the LoQ. If requested, a clarification meeting may be held in order to clarify open questions/ uncertainties regarding the list of questions and share experiences between the applicant, Swissmedic and WHO. |
| Day 151 – 240 (90 days) | Evaluation Assessment Phase 2 | In assessment phase 2 the technical reviewers evaluate the responses of the applicant to the LoQ. In general, assessment phase 2 results in a preliminary decision, which may be positive, partly positive or negative. In exceptional cases, a second LoQ may be issued Preliminary) assessment reports are shared with the the NRAs concerned. A case team meeting is held to present the outcome of Swissmedic’s review. Subsequently, the NRA’s experts are expected to study and comment on the Swissmedic assessment reports and to build their own opinion on the preliminary decision. A second case team meeting to discuss the outcome. All relevant concerns of the NRAs involved are added as recommendations to the preliminary decision. When appropriate, the application is presented and discussed at the meeting of the Swissmedic Medicines Expert Committee (SMEC) before finalisation of the preliminary decision. The Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) must be submitted in English and the correspondence language of the applicant (German or French). Swissmedic reviews and corrects the SmPC, PIL and the packaging material For export registrations, only the SmPC is required. In addition, Swissmedic translates and transfers the corrections to the English Version of the SmPC. This English version is shared with the NRAs involved and WHO on the electronic platform. The NRA’s experts may also comment on the SmPC and the corrections made by Swissmedic. |
| Day 240 | Preliminary Swissmedic Decision | Swissmedic informs the applicant of the preliminary decision to be made and any conditions that would apply to the final decision. With the preliminary decision, the applicant receives the comments and corrections on the SmPC, PIL and the packaging material. Applicant is granted a 60-day period to submit its response to the preliminary decision. The applicant is expected to agree with any obligation linked to the final decision as well as to fulfil all preconditions associated with the final decision. |
| Day 241 – 330 (90 days) | Labelling Phase | During the labelling phase the texts for the SmPC, PIL and packaging material are finalised. The applicant reviews the SmPC, PIL and packaging elements provided by Swissmedic. If all corrections are accepted by the applicant as demanded by Swissmedic, the final decision will be issued. If the applicant does not agree with all the comments and corrections, an additional labelling round may be needed. In this case, the applicant is granted another 60-day period for the reworking of the labelling elements, followed by a 90-day review period by Swissmedic. The time for the additional labelling review is at the expense of the applicant. For new products (i.e. first marketing authorisation) the approved SmPC and PIL must be published on the Swissmedic Product Information Publication System by the applicant. Export registrations do not need to be published. |
| Day 330 | Swissmedic Decision | Final decision sent to applicant and made available, together with the translation of the approved SmPC, PIL and finalised evaluation reports, to the NRAs concerned, via the electronic platform. In the case of a positive decision the Swiss marketing authorisation or export registration is granted. The dispatch of the final decision marks the end of the Swissmedic process. |
| Sample testing | Swissmedic performs sample testing in accordance with the instructions that apply generally to the authorisation procedure. Samples and any other documents must then be submitted in accordance with the requirements stated in the LoQ | |
| Day 420 (90 days) | National Decision by the NRAs concerned. | Provided the dossier has been submitted, the NRAs decide (if possible) on an authorisation within 90 calendar days after completion of the procedure at Swissmedic. If the dossier has not been submitted by the end of the Swissmedic procedure, the decision must be made within 90 calendar days after dossier receipt. |
In May 2020, Swissmedic authorised Carbetocin Ferring, an injectable solution for the prevention of uterine haemorrhage due to postpartum uterine atony. The decision represented a Swissmedic marketing authorisation according to the regulatory requirements in Switzerland. In the next phase of the procedure, the applicant submitted the dossier to the participating NRAs, which were expected to approve it in their respective jurisdictions within 90 calendar days from receipt.
Experts from the National Regulatory Authorities (NRAs) of Kenya, Uganda, Tanzania (mainland and Zanzibar), South Sudan, Nigeria, Democratic Republic of Congo and Ethiopia participated in the procedure to licence carbetocin Ferring, the first product to be granted approval via the MAGHP.
The MAGHP Light procedure was originally initiated as a response to the global COVID-19 pandemic and the need to accelerate the review processes and global access to life- medicines for the treatment of COVID-19. However, the geographical and medical scope of the MAGHP Light procedure is identical to the standard MAGHP procedure.
The MAGHP Light procedure:
- builds on the established MAGHP authorisation process as described in other sections of this blog post.
- foresees a one-directional exchange of documentation with the participating National Regulatory Authorities (NRAs)
The applicant indicates the interest in participating in the MAGHP Light procedure by compiling the respective section in the form New authorisation for human medicinal products HMV4 or in the form Variations and extensions HMV4, and specifies the countries/NRAs to be involved in the procedure. Swissmedic evaluates the MAGHP Light request and informs the applicant about the decision.
Sources: Swissmedic, Guidance document MAGHP Procedure
The MAGHP Light procedure is applicable to all applications in the Swissmedic fast track and temporary authorisation procedures. No other formal criteria must be fulfilled.
The geographical and medical scope of the MAGHP Light procedure is identical to the standard MAGHP procedure.
There are two distinct options for distributing the relevant documentation:
Option 1
- The applicant shares the application dossier directly with the targeted National Regulatory authorities (NRAs).
- After completion of the procedure, Swissmedic discloses the evaluation reports and correspondence (LoQ), preliminary decision and final decision including the summary of product characteristics) to the involved NRA.
- At the request of the marketing authorisation holder, Swissmedic will establish contact with the authorities concerned, via the WHO.
Option 2
After completion of the procedure, Swissmedic provides the targeted NRA with both the marketing authorisation dossier as submitted to Swissmedic as well as the evaluation reports and correspondence (LoQ, preliminary decision and final decision including the summary of product characteristics) produced during the Swissmedic assessment procedure.
The official submission of the application to the targeted NRAs remains for options 1 and 2, within the applicant’s competence and responsibility.
In both cases, the applicant grants Swissmedic permission to share confidential information with the targeted NRAs by means of a secured electronic platform.
The timelines valid for the MAGHP Light procedure depend on the specific timelines set for the type of application and procedure (i.e. Swissmedic fast track or temporary authorisation procedures).
Due to the shorter timelines set by the accelerated procedures, the MAGHP Light procedure is based on one-way communication with the involved NRAs. This means that the interactions between Swissmedic and the NRAs are limited to the NRAs accessing the information such as the dossier and evaluation reports. Swissmedic does not provide any type of exchange/interaction with the NRAs during the assessment period.
The need to clarify the procedure itself and/or specific questions about the submission from the participating NRAs may be addressed by email exchange.
In contrast to the standard MAGHP procedure, the MAGHP Light procedure does not imply expectations regarding the national decision phase in the targeted countries.
Further information is available on the Swissmedic website on this page here where links are provided to many guidance documents including the following:
- Guidance document on the MAGHP procedure – Provides detailed guidance on MAGHP procedure plus some guidance on MAGHP Light procedure
- Guidance document Scientific Advice MAGHP – Provides Detailed guidance on the Scientific advice procedure
- Leaflet “Swissmedic -MAGHP Procedure” – for very basic details about the procedure
Also available is a link to recording of a Virtual Event on the MAGHP Procedure from March 2021 entitled A contribution to accelerating access to quality medical products in low and middle-income countries. The slides presented in this virtual event are available here.
Please share any comments on this post via the feedback page.