European Regulatory Roundup: EC Opens Draft Consultation on Advanced Therapy GMP Guidelines (30 June 2016)

Regulatory NewsRegulatory News | 30 June 2016 |  By 

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EC Opens Draft Advanced Medicinal Products GMP Guidelines for Consultation

The European Commission (EC) has posted draft guidelines on good manufacturing practices (GMPs) for advanced therapy medicinal products (ATMPs). EC is particularly keen to receive feedback from academics and representatives of small and medium-sized enterprises (SMEs), groups that would be strongly affected by excessively prescriptive regulations.

As it stands, many gene therapies, somatic cell therapies and tissue engineered products — the types of therapeutics classed as ATMPs — are developed at academic centers, hospitals and SMEs. These organizations, particularly academic centers and hospitals, have different quality systems than those in place at conventional drug production plants. In light of this and the fact that knowledge about the potency and optimal manufacturing process for experimental ATMPs will evolve during development, EC is willing to take a flexible regulatory approach provided quality, safety and efficacy are assured.

This thinking has led EC to propose a risk-based approach to GMPs, a model that places the onus for designing the organizational, technical and structural measures needed to comply on manufacturers. In doing so, EC has tried to ensure that organizations that work differently, but no less effectively, are not encumbered by overly prescriptive guidelines. The approach also recognizes that the term ATMP covers a broad range of products, which have significant variances in the risks associated with them. What is safe and appropriate for one type of ATMP may be unsuitable for another.

EC decided on the risk-based approach after gathering feedback from the ATMP industry for several years. That process informed EC that some in the sector felt the special characteristics of ATMPs, such as the variability of starting materials and personalized end products, made it desirable to have GMPs tailored to its needs. It also revealed a rift between academia and industry, though. One in five respondents, mainly from industry, expressed negative opinions about EC's original proposal, in part because it was perceived as creating a two-tier system.

Now, the industry has a chance to comment on whether the finished draft document, which states the flexibility it provides is available to all organizations, suffers from these perceived shortcomings. EC is accepting feedback on the text until 26 September.

Draft Guidelines

EMA Proposes Terms of Debate About Stem Cell Products for Veterinary use

The European Medicines Agency (EMA) has initiated a debate about the quality evaluation of stem cells products for veterinary use. Officials want to discuss the regulations and approaches that are needed to ensure stem cell products are free from viruses, bacteria, protozoa and other extraneous agents.

EMA's Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) released details of the topic in a draft document featuring three questions it plans to discuss. The questions seek to ascertain whether existing guidance on keeping stem cell products free from viruses and bacteria is sufficient to support the safe use of such therapies in horses and dogs. If not, ADVENT wants to know whether additional guidance focused on the specific requirements of stem cell therapies for horses and dogs would be helpful to the industry.

The other questions cover guidance on ensuring freedom from parasites and strategies to control and analyze extraneous agents. As it stands, the European Union is yet to establish guidance on how to show stem cell therapies designed for horses and dogs are free from protozoa and other parasites. EMA wants to know which protozoa it should focus on as it addresses this gap in its guidelines. The regulator is also seeking recommendations on other strategies to control, analyze, mitigate and manage the risks associated with extraneous agents in veterinary stem cell therapies.

ADVENT outlined the terms of the discussion following a review of scientific information regarding extraneous agents. This led to the identification of the three questions ADVENT wants answered. When the feedback period on the draft questions closes at the end of September, ADVENT will work to address the questions. This process is expected to lead to the development of a question and answer guidance document.

Draft Questions

Swissmedic Ends Campaign to Tackle Illegal Fresh Cell Therapies

The Swiss Agency for Therapeutic Products (Swissmedic) has ended its campaign against fresh cell therapies, a class of products defined by the injection of living cells from young calves or lambs into people. Swissmedic has spent the past 18 months investigating the sector, leading to it issuing rulings against four manufacturers and suppliers.

Officials in Switzerland first became interested in the sector in 2011, when an increase in Chinese visa applications for medical treatment in the European country led to questions being raised through the Federal Department of Foreign Affairs. Terms such as "fresh cell therapy" and "sheep placenta injections" were used to describe the purpose of the medical tourism, but neither Swissmedic nor the Federal Office of Public Health (FOPH) had authorized such treatments. Further research showed some clinics were promoting the therapies as strengthening the immune system.

In 2014, local officials identified 37 institutions suspected of offering such treatments, after which they asked the clinics to complete a questionnaire regarding their activities. Subsequently, seven of the institutions stopped operating. A further nine sites were cleared of any wrongdoing. This left 21 cases for Swissmedic to investigate. The regulator found none of the sites offered treatments that met its original definition of fresh cell therapies — preparations derived from living animal cells or tissues — but it did ask 14 of the institutions to correct information on their websites.

Swissmedic also issued three official decisions against institutions it accused of manufacturing and administering extracts prepared from animal tissue. The clinics have appealed the rulings and are waiting on court decisions.

The investigation has coincided with a period in which applications for medical visas from China have fallen sharply, although Swissmedic is unsure if the trend is a direct consequence of its actions. In 2013, Switzerland received approximately 1,000 applications. Last year, the number had fallen to 300.

Swissmedic Statement

EMA Seeks Feedback on Veterinary Medicine Safety Proposals

EMA has released a draft guideline on user safety of topically administered veterinary products. The creation of the document follows a period in which the number of applications for such products has increased.

Faced with this trend, EMA's Committee for Medicinal Products for Veterinary Use (CVMP) has decided it needs a "coherent and common approach" to the assessment of exposure to topical products. CVMP used the United States Environmental Protection Agency's (EPA) Standard Operating Procedures for Residential Pesticide Exposure Assessment as the starting point for its guideline, but has modified some of the algorithms used in that document.

The result is a 26-page guideline that draws on the EPA text and documents prepared by the Dutch National Institute for Public Health and the Environment to deliver advice on creating safe topical products. Such medicines pose a risk to users when they are spilled and when people come into contact with animals following administration of the product.

CVMP recommends the use of "wipe tests" to assess the risk of medicinal residues being dislodged from animals and harming people. The committee also provides details of factors that developers should consider when working on particular types of products, such as spot-on solutions, shampoos and sprays.

EMA is accepting comments on the text until the end of December.

Draft Guideline


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