European Regulatory Roundup: Swissmedic Proposes Overhaul of Drug Ordinances (29 June 2017)

Regulatory NewsRegulatory News | 29 June 2017 |  By 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Swissmedic Proposes Overhaul of Drug Ordinances to Simplify Authorizations

The Swiss Agency for Therapeutic Products (Swissmedic) is rewriting its ordinances to simplify the authorization of drugs in certain situations. Swissmedic embarked on the comprehensive overhaul of the regulations in response to changes to the Therapeutic Products Act that were finalized last year.

Swiss officials are preparing to implement some of the changes and associated ordinances at the start of next year. This first wave of revisions covers national recommendations on pediatric drug doses and definitive arrangements for medicinal products approved by political subdivisions of the country. However, while Swissmedic is already prepared to implement these changes, it wants to gather the views of industry before enacting other revisions necessitated by the new legislation.

Some of the changes are designed to facilitate market access. Swissmedic singled out medicines already approved in a Swiss canton or European Union member state, products with traditional uses and complementary therapies as having a simpler path to market under the proposed regime.

The proposals also place new pressures and requirements on companies. The time Swissmedic gives applicants to fix problems with their submissions is set to shrink from 120 days to 30 days. Swissmedic thinks the current timeframe is too long and rarely required. Shortening the window is intended to improve regulatory workflows. Firms that fail to fix a filing within the allotted time can refile later without facing regulatory prejudice.

Swissmedic is also using the changes to adapt its processes to two of the big regulatory changes in the neighboring EU region: pharmacovigilance and the publication of clinical trial data. Swissmedic expects companies that win approval in Switzerland for products containing new active ingredients to publish their trial data within three months of getting the regulatory nod. However, Swissmedic does not plan to check whether the results are published and is placing no constraints on where they are made available.

The pharmacovigilance requirements apply to companies with new active ingredients and those that gain clearance to use existing products in new indications. Swissmedic is referring companies to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E2E guide on pharmacovigilance planning for advice on how to approach the matter.

These proposals and others covering rebates, transparency and mail order drug sales are up for debate. Swissmedic is seeking feedback on the changes until 20 October. Currently, the aim is to bring the revised ordinances into force at the start of 2019. However, Swissmedic will only commit to a date once it has assessed the responses to the consultation.

Swissmedic Statement

EMA Starts Consultation on Planned Changes to Vaccine Trial Guidance

The European Medicines Agency (EMA) is seeking feedback on its plan to rethink its position on the clinical development of vaccines. EMA wants to update its guidance on topics including comparative immunogenicity studies in response to the experience it has gained since adopting the current document in 2007.

Officials think most of the advice in that earlier guidance document is still appropriate and relevant. The problem is the document lacks sections covering topics EMA has come to see as important. In response, EMA has published a draft concept paper to get industry input on a regulatory revision process it sees as leading to the adoption of new guidance late next year.

EMA has identified more than 15 areas it wants to address in the revised guidance. The establishment of a new position on comparative immunogenicity studies tops the list. Specifically, EMA wants to discuss the interpretation of results intended to show a vaccine triggers a better or non-inferior immune response than an existing product. EMA’s desire to address the challenge of assessing vaccines that seek to improve on existing products was one of the motivations for revising the guidance.

Other topics up for discussion include when sponsors can skip age de-escalation studies, the use of different vaccines for priming and boosting the immune response, the selection of control groups and vaccination during pregnancy to protect the mother and infant. Another group of topics relates to vaccine safety. EMA plans to address how the type and novelty of a vaccine affects the size of the pre-licensure safety database, the stratification of safety databases by patient subgroup and circumstances in which limited pre-licensure safety data is acceptable.

EMA is accepting feedback on its plans to address these topics until the end of September. The agency then plans to work on the draft guidance with a view to releasing it for a six-month consultation period in the first quarter of next year.

Concept Paper

CVMP Adopts First Guidance on Stem Cell Veterinary Therapies

EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) has adopted the first guidance on stem cell therapies for use in animals. The document covers concerns raised by regulators and industry about the sterility of allogeneic stem cell-based products.

CVMP’s Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) put together the question and answer document after identifying an uptick in the use of allogeneic stem cell-based products in animals. As parenterals, these products must be free from bacteria, fungi and mycoplasma. However, as the active ingredients in such products are living cells, physical and chemical methods used to sterilize other types of therapy are unsuitable for use in this context.

To address uncertainties created by this limitation and other aspects of stem cells, ADVENT has posed and answered eight questions. The document advocates the use of overall microbiological control strategies that combine finished product testing with in-process controls and qualification of the purity of starting materials. Sterility tests for the absence of mycoplasmas and endotoxins are a non-negotiable part of release specifications.

The guidance also covers how to counteract the difficulty of implementing aseptic techniques when sourcing cells, when it is critical to test for sterility, which rapid microbiological methods are acceptable and whether the presence of endotoxins is a safety concern.

Adoption of the text represents the start of a planned wave of documents covering the use of novel technologies in veterinary medicine. EMA is working on guidance documents about cell therapies and monoclonal antibodies.

Press Release, Adopted Q&A

EMA Sets May 2018 Date for Implementation of VICH Text on Waiving Animal Tests

EMA has adopted Veterinary International Conference on Harmonization (VICH) criteria for waiving animal tests. The document harmonizes the criteria used to waive target animal batch safety testing for inactivated veterinary vaccines.

VICH created the document to reduce animal testing by freeing manufacturers from the need to run separate studies to gain approval in different markets. Originally, VICH hoped to harmonize all aspects of batch safety tests, but refined its focus after assessing the current degree of divergence in practices at regulators around the world. VICH selected criteria for waiving target animal batch safety testing for inactivated veterinary vaccines as its first target.

The document is due to come into force in the EU on 1 May, although it will have less impact there than in other VICH regions. EMA dropped the target animal batch safety test from its list of studies that must be run to win approval in 2013. The United States and Japan still require companies to run the tests in certain circumstances.

VICH’s guidance sets out a standard approach for when regulators should waive the need to run the tests.

VICH Document


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