Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
MHRA Offers Advice on use of Brand Names to Prescribe Drugs
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guideline on the naming of medicinal products. MHRA’s most substantive change is the addition of a new section that provides general recommendations for brand naming and prescribing.
In some cases, products are approved for use and subsequently prescribed by brand name alone. The updated MHRA guideline details factors it will consider when assessing if this is the right approach for a particular product, as well as the additional steps manufacturers may need to take when their products are approved with a brand or generic name.
The situation is most straightforward for biologics and biosimilars. MHRA will only approve these products with brand names so it can differentiate between safety reports filed about biologics and their biosimilar copies. The UK may change that rule once it has more data on biosimilar switching.
Multiple factors dictate whether a small molecule product will be approved only by brand name. In the guideline, MHRA states it will consider whether the therapeutic index of a drug raises the risk of toxicity and the severity of the clinical consequences of toxicity when making assessments about the use of brand names.
MHRA will also look into the availability of non-equivalent branded drugs, the use of novel excipients that affect safety and efficacy and the potential for differences in reconstitution or dilution to lead to medication errors. MHRA will permit the generic naming of prolonged-release drugs, provided they are licensed as generics, are bioequivalent to the reference product and free from interchangeability issues.
When a product is approved by brand name only, MHRA recommends authorization holders consider running a communication campaign to ensure healthcare professionals understand the situation. Equally, MHRA foresees the need for extra provisions regarding some drugs with generic names, such as the inclusion of a trademark to ensure continuity of supplier.
MHRA provided the advice as part of its first update to the guideline in 10 years. The agency also added a new section on how to avoid the harmful effects that can arise when switching between solid oral dose antiepileptic medicines. Elsewhere, MHRA made multiple small changes to the main body of the text, such as the removal of a recommendation against the incorporation of company names or trademarks into the names of medicinal products.
France Issues Notice About Risk of Substituting AstraZeneca Cancer Drug
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a notice about the risk of substituting the capsule and tablet formulations of AstraZeneca’s Lynparza.
A tablet formulation of PARP inhibitor Lynparza came to market in France this week. A capsule form of the drug was already available through the same pharmacy channels. That creates a potential risk of medication errors, as capsules and tablets cannot be substituted on a milligram to milligram basis because of differences in bioavailability.
To avoid errors, ANSM is advising physicians to specify the Lynparza formulation and dose on each prescription. Pharmacists should then ensure that the correct formulation and dose are dispensed. Healthcare professionals should explain the situation to patients switching between dosage forms.
The advice is the same as that provided in other parts of the world where the tablet version of the drug came to market earlier than in France.
Swissmedic Expands Effort to Improve Labeling Review After Pilot Project
The Swiss Agency for Therapeutic Products (Swissmedic) is set to revise its approach to the review of product labels based on experience gained in a pilot project. Swissmedic began testing the new ways of working in 2017 in a bid to significantly reduce the number of text review phases.
Swiss officials began the pilot project in response to “disproportionately long labeling phases.” To truncate the labeling phase, Swissmedic began providing feedback on the information for healthcare professionals and packaging elements at the list of questions stage. Swissmedic also asked companies to submit definitive versions of their packaging materials with their initial applications and shortened the window granted to applicants to reply to preliminary decisions by 30 days.
When the pilot phase began, Swissmedic said it would continue to assess the measures until it had data to form reliable conclusions about the feasibility and effectiveness of the proposals. Swissmedic now has that data, prompting it to end the pilot project and commit to rolling out the new ways of working.
Going forward, Swissmedic will send comments on the packaging elements with the list of questions for all relevant applications. Swissmedic has already adopted some of the other measures through prior initiatives, such as the revision of the Therapeutic Products Act. As such, the labeling process now in place in Switzerland resembles the one Swissmedic put through pilot testing.
EMA Updates Position on Raft of Post-Authorization Veterinary Medicine Topics
The European Medicines Agency (EMA) has updated multiple question and answer documents about post-authorization processes for veterinary medicines. EMA’s updates include new sections covering the imposition of post-authorization requirements on newly approved veterinary medicines.
The Q&A on post-authorization measures features four new sections. These sections explain what post-authorization measures, specific obligations, annex II conditions and recommendations are and what they mean for manufacturers of veterinary medicines. Collectively, the sections detail how and why the Committee for Medicinal Products for Veterinary Use (CVMP) may request extra data.
CVMP will use specific obligations in exceptional circumstances in which it will permit a medicine to come to market with limited safety and efficacy data, such as when the product targets an indication that is too rare to study. Products subject to specific obligations must undergo annual reassessments informed by ongoing data collection. In other cases, CVMP will make nonbinding recommendations to encourage further development of a product.
EMA’s CVMP also added two new sections to its Q&A on renewals. One of the new sections walks through the process for renewal applications, from the formatting of cover letters to the filing of statements from quality and safety experts. The other new section details when linguistic checking of product information takes place.
Multiple other sections of the Q&As on post-authorization measures and renewals have undergone revisions. CVMP also revised aspects of two other Q&As, which address how to change the names of centrally authorized products and transfer authorizations to other organizations.
Changes to the transfer document include revised advice on the timetable for transfers. Previously, EMA told companies to notify it of their intention to transfer an authorization before doing so. The revised Q&A provides more detail, describing a 30-day procedure. If the application is correct and complete, EMA aims to finalize the procedure within 10 days. EMA will tell applicants if they need to provide additional materials within 10 days.
, Name Change
has published a joint statement with three groups representing healthcare professionals. The statement sets out goals shared by the organizations with a view to facilitating closer cooperation. The common goals include helping EMA to better understand how drugs are used in the real world and the impact of regulatory actions on patient care. Press Release
, Joint Statement
The European Council
appointed four people to the EMA
management board. Council Decision