European Regulatory Roundup: EMA Posts Recommendations on Advanced-Therapy Medicinal Product Classifications (27 August 2015)

Regulatory NewsRegulatory News | 27 August 2015 |  By 

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

EMA Posts Recommendations on Advanced-Therapy Medicinal Product Classifications

The European Medicines Agency (EMA) has updated its list of summaries of recommendations on the classification of advanced-therapy medicinal products (ATMPs). Melanoma-derived lymphocytes, allogeneic cord blood cells and other forms of ATMPs are discussed in the newly-added documents. 

A cached version of the page shows that as of 26August, the last document to have been uploaded was adopted on 29 October. Since then, EMA has adopted 14 more scientific recommendations, each of which is now available on its list of ATMP classification summaries. The documents state whether a particular product is classed as a somatic cell therapy, tissue-engineered treatment or a gene therapy, plus a brief explanation of the regulator's reasoning.

Half of the new summaries class the products as somatic cell therapies, while a further five put the treatment in question under the gene therapy umbrella. The regulator classed an AAV vector-based treatment for retinitis pigmentosa as a gene therapy. Finally, EMA ruled in vitro-derived platelets fall outside of the scope of the ATMP classifications because they lack a nucleus. As such, they are not considered to be cells under the ATMP classification criteria.

Scientific Recommendations

UK Threatens Doctors with Jail as Plans for Sunshine Rule Accelerate

The United Kingdom is to bring in transparency rules next year that will allow courts to sentence healthcare professionals to 10-year jail sentences for having improper financial ties to drugmakers. Health secretary Jeremy Hunt unveiled the plan in response to a media investigation into payments made by biopharma companies.

Writing in The Telegraph, the newspaper that spearheaded the investigation, Hunt said the evidence suggests "some sales reps have been ripping the [National Health Service] off." The goal for Hunt now is to enact a policy that stops such abuse of the healthcare system without hindering "sensible" cooperation. A rule based upon the Sunshine Act the US passed in 2013 is in the works. Once in place, the rule will make disclosure of financial relationships with the industry mandatory. 

At this stage it is unclear what gifts and hospitality would be covered by the rule—payments of less than $10 are excluded in the US—but the Hunt has already talked up the penalties for failing to comply. The plan is to enable the prosecution of wrongdoers under the Bribery Act, which allows courts to sentence convicts to up to 10 years in jail and enforce unlimited fines. The Association of the British Pharmaceutical Industry (ABPI) welcomed the proposal.

The Telegraph, Press Association, Pharmafile

Swissmedic Updates Strategy on Veterinary Medicines

Swissmedic has established a new strategy for veterinary medicines. The Swiss regulator has set up the policy in response to the creation of the Federal Food Safety and Veterinary Office (FSVO), which was formed last year through the merger of two existing units.

Having reassigned responsibilities, Swissmedic is now focused on marketing authorizations and the monitoring of approved veterinary medicinal products. The regulator is the main contact for these areas. FSVO has taken responsibility for the safe use of veterinary drugs, as well as issues relating to the use of antibiotics in animals. The newly-formed unit is also supporting the implementation of the Veterinary Medicinal Products Ordinance (VMPO), which was revised when FSVO was set up in 2014.

The reshuffle has allowed Swissmedic to concentrate its veterinary medicine expertise in a single unit, the Veterinary Medicinal Products Department (TAM). TAM, part of the authorizations side of the organization, is now handling all aspects of the safety of veterinary medicines but will continue to collaborate with VetSuisse and TAM-Vigilance. The Institute for Virology and Immunology (IVI) has retained oversight of vaccines and sera for animals.  

Swissmedic Notice

MHRA Teams up with DIA to Offer 5-day Pharmacovigilance Training Course

The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has teamed up with the Drug Information Association (DIA) to offer a pharmacovigilance course. MHRA and DIA have scheduled the five-day course for the week starting 28 September at a hotel in London.

Officials at the regulator have set up the course to help qualified persons for pharmacovigilance and people involved with clinical research, regulatory affairs and other fields to get up to date with the topic. MHRA and DIA are pitching the course as a way for people to get a grounding in the essentials of pre- and-postmarketing safety regulatory requirements in Europe and beyond, as well as efforts to harmonize and standardize the field.

Specific areas of focus for the course include definitions and methods of pharmacovigilance, plus regulatory aspects of the field and practical examples. MHRA and DIA will also cover the assessment of the safety of medicinal products, the identification and handling of adverse events, signal detection and management and risk management. The collaborators have previously held joint workshops on statistics and advanced-therapy medicinal products (ATMPs).

MHRA Notice

Boehringer, Lilly Introduce Lantus Biosimilar in UK

Boehringer Ingelheim and Eli Lilly have started selling a biosimilar version of Sanofi's Lantus in the UK, PMLiVE reports. The partners are selling the biosimilar at a 15% discount to Lantus, sales of which have started to suffer as a result of competition from biosimilars and innovative rivals.

European regulators approved the biosimilar one year ago and the product is already on sale in some markets in Eastern Europe, notably the Czech Republic, Slovakia and Estonia. The UK is the first major European market in which the drug has gone on sale, though. Lilly thinks the product offers something more than just cost savings.

"[The biosimilar will] help expand available therapeutic options to address individual patient needs and should provide additional value beyond cost savings," a spokesperson for Lilly told PMLiVE.


Other News:

MHRA has released a fees calculator to help companies figure out how much they will be charged for filing for marketing authorization. MHRA put together the calculator in response to the number of license applications that are invalidated when companies fail to pay the correct fee. MHRA Statement

EMA has posted a draft addendum to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 (R2) guideline on good clinical practice (GCP). The draft is open for comment for the next six months. The proposed changes are designed to support the design of more efficient clinical trials. EMA Notice, Draft Addendum

MHRA has issued a medical device alert about sterile electrosurgical forceps and electrodes sold by Zethon and Ross Electro Medical. The notice alerts healthcare professionals to the recall of certain batches of the products that may not be sterile. Affected batches are to be returned to Zethon. MHRA Notice

Dr. Mike Durkin, director of patient safety at NHS England, has shared more information about the Independent Patient Safety Investigation Service (IPSIS) that is due to start up in April. IPSIS is intended to ensure incidents in the healthcare system are investigated properly, resulting in patients and their families having their questions answered more thoroughly and quickly. Durkin Statement

MHRA has alerted healthcare professions to a fault with the charging base of surgical hair clippers from Medline Industries. The alert was prompted by the realization the overheating of defective charging bases could cause a fire in  oxygen-rich environments. MHRA Notice


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