Drug Regulators Publish Draft Guidance, on Advanced Therapy Medicinal Products, under the Hospital Exemption Scheme.

The MHRA publishes Draft “REGULATION (EC) NO 1394/2007 ON ADVANCED THERAPY MEDICINAL PRODUCTS (“THE ATMP REGULATION”) GUIDANCE ON THE UK’S ARRANGEMENTS UNDER THE HOSPITAL EXEMPTION SCHEME

Purpose of this Guidance

This draft guidance has been developed by the Medicines and Healthcare products Regulatory Agency (MHRA) and aims to clarify the arrangements that will apply in the UK under the hospital exemption scheme under Article 28 (2) of the ATMP Regulation.

Scope

This guidance outlines the requirements that will apply to advanced therapy medicinal products (ATMPs) made and used under the hospital exemption scheme in the UK.

Introduction and Context of Exemption

The ATMP Regulation entered into force on 30 December 2007 and applied from 30 December 2008. Under the ATMP Regulation, those medicinal products which come within the scope of Directive 2001/83/EC and are categorised as ATMPs are to be regulated under the centralised European procedure. Within the Regulation there is an exemption for ATMPs which are prepared on a non routine basis and used within the same Member State in a hospital in accordance with a medical prescription for an individual patient.

Requirements Under the Exemption

The Regulation stipulates that manufacture of ATMPs under the hospital exemption must be authorised by the Member State (the MHRA in the UK). In addition, traceability, quality and pharmacovigilance standards for ATMPs made under the exemption must be equivalent to ATMPs for which a centralised market authorisation would be granted by the EMEA.

Relationship between the Hospital Exemption and the Directive 2001/83/EC

Although the two schemes are legally distinct, there are some apparent similarities between the kind of activities falling within the hospital exemption and the UK “specials” scheme set up under the derogation permitted in Article 5 (1) of Directive 2001/83/EC. MHRA advice to operators who are uncertain about which of the two schemes may be applicable is as follows:

• Check this guidance to identify the main conditions relating to the hospital exemption and check MHRA’s Guidance Note 14
• Seek advice from the MHRA about which scheme is applicable

There are also currently significant differences in the regulatory requirements relating to products coming within the scope of the two schemes. This guidance sets out the requirements relating to good manufacturing practice, pharmacovigilance, traceability and patient information under the hospital exemption

Standards That Are Required Under the Hospital Exemption

GMP (good manufacturing practice)

Under the Regulation, there is a requirement for manufacture under the hospital exemption to be authorised by the competent authority of the Member State. In the UK a manufacturer will be required to obtain a manufacturer’s licence from the MHRA.

Pharmacovigilance

Manufacturers operating under the hospital exemption will be required to record any adverse reactions to an ATMP and notify the MHRA of any suspected serious adverse reactions.

Traceability

The hospital in which the ATMP is used will be required to establish and maintain a system for patient and product traceability containing sufficient detail to enable traceability between recipients of ATMPs and donors of the tissues and cells used in their manufacture.

Reporting Requirements

Manufacturers operating under the hospital exemption will be required to make an annual return to the MHRA. This return must set out the activities that are being carried out under the scheme. This must include a description and number of batches and units manufactured in each of the three categories of ATMPs for which a manufacturer’s licence has been granted.

The guidance goes on to discuss the requirements of wholesale dealers, labeling, package leaflet requirements, advertising and ethical issues.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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