Optimisation of labelling phase

Background
Over the past four years, in a joint working group with representatives from the pharmaceutical industry, Swissmedic has been conducting a benchmarking study on authorisation periods. An analysis of the study results indicated that the labelling phase shows potential for improvement. Following an in-depth process analysis, the working group has drawn up proposals for measures (process changes) designed to make the labelling process more efficient and to significantly reduce the number of additional text review rounds, which are the primary cause of disproportionately long labelling phases. These measures have been reviewed and approved for implementation by Swissmedic's Management Board. The measures will now be implemented, in a pilot phase, for human and veterinary medicinal products.

Pilot phase
The impact of the process changes on the total throughput times and the labelling phase will be tested in a pilot phase. The pilot phase will start on 1 October 2017. Individual measures (measures 1c, 2 and 3; see below) will also be applied to ongoing applications that have not yet reached the labelling phase by 1 October.
If the measures in the pilot phase fail to achieve the desired effect, they will be adapted or cancelled. The pilot phase will end as soon as sufficient empirical results have been obtained to enable reliable statements to be made about the practical feasibility and efficacy of the measures.

Measures/Process changes in detail
1. Feedback on Information for healthcare professionals and packaging elements already at the List of Questions stage (frontloading)
a) Feedback on the Information for healthcare professionals

Content
For all new applications submitted for medicinal products with new active substances, Swissmedic will provide, already with the List of Questions (LoQ), feedback on the Information for healthcare professionals in the form of revised manuscripts. The scope and depth of the feedback on the Information for healthcare professionals can vary depending on the questions that are still unresolved after evaluation phase I.
The aim of this measure is to initiate the labelling dialogue with the LoQ so that the versions of the Information for healthcare professionals and Patient information available at the time of the preliminary decision are as consolidated as possible.

Preconditions

• The Information for healthcare professionals is thoroughly prepared in terms of both form and content and adequately reflects the entries on the authorisation application.
• Approval of the application is likely after the LoQ have been answered.

Applicability
Applications for medicinal products with new active substances submitted from 1 October 2017.
b) Feedback on packaging elements (cartons, blisters and labels)

Content
Applications for the authorisation of medicinal products containing known active substances, in particular, often involve additional labelling rounds because the packaging material does not satisfy Swissmedic's requirements. In future, applicants should, whenever possible, submit the definitive versions of the packaging material (design layouts / mock-ups) already when the initial application is submitted. In such cases SMC will review these documents already at evaluation phase I and provide feedback with the LoQ.
The aim of this measure is to ensure that packaging materials have already been reviewed and satisfy Swissmedic's requirements by the time of the preliminary decision.

Preconditions

• Cartons, blisters and labels will be submitted already with the initial submission in the form of design layouts (mock-ups).
• Approval of the application is likely after the LoQ have been answered.

Applicability
New applications and applications for major variations submitted from 1 October 2017.
c) Shortening of company time limits in the labelling phase

Companies are currently granted a standard period of 90 calendar days for replying to the preliminary decision and for any additional text review rounds. This period will be shortened to 60 CD. In future, a time limit of 30 CD will be specified for replying to a text review letter. As before, the applicant will still be able to request an extension of the time limit if necessary. The Swissmedic time limits for the labelling phase (90 CD) will not be modified during the pilot phase. However, if the review does not involve a lot of work, Swissmedic does not usually make full use of the time limits.

Preconditions

• None

Applicability
New applications and applications for major variations submitted from 1 October 2017 or that have not yet reached the preliminary decision milestone by 1 October 2017.
2. In-depth sharing of information between SMC and the company in the labelling phase

Content
The Swissmedic eGovernment Portal enables confidential information to be shared securely with the applicants. In future, Swissmedic will also use the portal to share information with applicants without having to interrupt the SMC evaluation phase.
The aim of this measure is to clarify fairly simple, unresolved questions within 5 calendar days (CD) in a direct dialogue via this option during the labelling phase. Official text review rounds with longer time limits (see under 1c) should be initiated only when more time is required to clarify unresolved points (e.g. due to more comprehensive investigations).

Preconditions

• The applicant is an eGovernment Portal user
• The unresolved questions can be answered by the applicant in a short amount of time (max. 5 CD).

Applicability
New applications, applications for major variations submitted from 1 October 2017 or that have not yet reached the preliminary decision milestone by 1 October 2017.

3. Exercise of official authority

Sometimes the total throughput time for applications is extended by additional text review rounds without the applicants submitting new facts that would form the basis for modification of the product information texts. In such cases, Swissmedic can, after granting the due process hearing, issue an official decision directly, without additional text review rounds. The product information texts with Swissmedic's corrections form an integral part of the official decision.
In these cases, the applicants still have the option of lodging an appeal with the Federal Administrative Court.

Preconditions

• None

Applicability
New applications and applications for major variations submitted from 1 October 2017 or that have not yet reached the preliminary decision milestone by 1 October 2017.