A new table summarizing the additional Data requested for New Application in the MRP/DCP which are not stated in the current EU legislation and /or volume 2B is available on the CMDh website. To view the table, please click on the link below: http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/CMDh_043_2007_Rev5_August10.pdf

New CTA regulations are applicable to all submissions, including amendments, in Poland. Submissions can no longer be done by a CRO but by a physical person, who can however be an employee of the CRO. Also two letters of authorisation are required, one from the sponsor authorising the legal representative and the second from the legal representative authorising the physical person in Poland. Less than 3 month old, proofs of establishment are needed for both the sponsor and the legal representative.

A new template for cover letter for new Marketing Authorisation application is available in the HMA website.

http://www.hma.eu/uploads/media/Cover_letter_for_new_MA_application_Final-_EXT-579873-2008.doc

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have developed a pilot programme of joined GMP inspections for manufacturers of medicinal products. This scheme applies both to Companies submitting in parallel two equivalent new marketing authorization applications for the same drug to both agencies and to Companies hosting one single re-inspection instead of two when the EMA and the FDA have planned separate routine surveillance inspections of a manufacturing within a similar time frame.

Companies interested in the scheme should contact gmp@ema.europa.eu or  CDERInternationalGMP@fda.hhsgov.

From Friday 8th October 2010 and over four weekends, the MHRA will be moving to its new location at 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ. MHRA will ensure minimal disruption to services during the move.

The Committee for Medicinal Products for Human use (CHMP) has issued a draft statement for consultation on the use plasma- and urine-derived medicinal products and Creutzfeldt-Jakob disease. The CHMP points out the importance to investigate the capacities of the manufacturing process for plasma-derived products as the available data support the reduction of infectivity by steps in this process. The CHMP also encourages the use of a number of exclusion criteria for selection of plasma and urine donors. There is no recommendation to recall batches if information becomes available post-donation since the donor exclusion criteria are very conservative.

The Committee for Medicinal Products for Human use (CHMP) has issued a statement on the use of Advanced Therapy Medicinal Products (ATMP) and Creutzfeldt-Jakob disease. ATMPs are subject to three types of considerations. For cell based products from autologous donors no specific considerations are required. For cell based products from allogeneic donors, the WHO guidelines on tissues infectivity should be considered as part of a risk-benefit assessment. For cells from umbilical cord, in both autologous and allogeneic transplantations, the level of contamination is considered extremely low since vertical transmission in humans has not been observed in any prion disease but can not be definitely excluded.

The guideline on the investigation of bioequivalence from the Committee for Medicinal Products for Human use (CHMP) came into effect on the 1^st August 2010. This guidance contains detailed descriptions on how pharmacokinetic-based bioequivalence studies should be conducted and evaluated as well as recommendations for biowaivers.

Marketing authorisation holders for medicines for which the marketing authorisation  was  granted before 30 October 2005 had a 5 years transitional period to amend the labelling to comply with Articles 54(a), 54(e) and 56(a). The MHRA has reminded MAHs to submit their applications by the 1 August 2010 to ensure compliance  by 30 October 2010.

The new requirements to comply with the above articles are:

• displaying the common names of the active substances clearly on the packaging
• including a space for the prescribed dose to be indicated
• displaying the name registered in section 1 of the SmPC in braille on the packaging

The MHRA has reminded marketing and manufacturing authorisation holders to keep all API manufaturing sites named on approved marketing authorisations actively maintained as approved suppliers in line with European GMP expectations. If  Companies do not want to maintain back up API manufacturers to GMP requeirement, they should remove them from the MA by submission of a Type A variation.