CERTIFICATE OF SUTABILITY
Submitted by aarti on Thu, 05/10/2012 - 09:44
Dear All, Hello, CERTIFICATE OF SUTABILITY As India is the "HOTSPOT' of API, Indian companies are aggressively eyeing the generics opportunities in Foreign Market. All though US is still the largest pharmaceutical market and has been the prime target for generics players across the globe, Indian companies are targeting in other markets such as Europe ,as there is tremendous difference in the cost of production and the labor cost in Europe and India. So, the Opportunity is more. Entering in foreign market is not easy task, one need GATEPASS for it. And in Pharma language this gate pass is the" Documents in the format as per the country'. While talking about API the Documents are mainly DMF (Drug Master File for US), EDMF (European Drug Master File), and COS/CEP (Certificate of Suitability) In this competitive Market every company is trying to do the best, to be at the top. In last few years competition makes almost every company to file DMF for their product. But the chapter wont closed at the DMF or EDMF only. So trying to seek the best position in the Domestic as well as in the foreign market the Pharma Company are Focusing on the CEP. Considering the stringent requirement of the Regulated Market, filing CEP is not simple business. So in this blog I am trying to focus on the CERTIFICATE OF SUTABILITY WHAT IS CEP? The CEP confirms that pharmaceutical substances or active pharmaceutical ingredients (API) are produced according to the monographs of the EP. The CEP bridges between European Pharmacopoeia monographs and the need to prepare a file for licensing and thus it also bridges between industry and health authorities. The CEP is facilitating and simplifying exchanges between the partners to ensure that the quality of substances is guaranteed and that these substances comply with the European Pharmacopoeia and therefore the requirements of EU directives for medicines. WHO NEEDS IT? Manufacturers or suppliers needing or wanting to apply for a marketing authorization for: * active substances or excipients to control the chemical purity and microbiological quality of their substance, * products with TSE risk to evaluate the reduction of TSE risk according to the general monograph, * herbal products used in the production or preparations of pharmaceutical products to be evaluated according to the suitability of the monograph for the control of herbal drugs and herbal drugs preparations. Described in Resolution AP CSP 1 and Directives 2001/83/EC, 2001/82/EC ADVANTAGES OF THE CEP * full confidentiality of the submitted data, * centralized evaluation by the EDQM, * recognized by all Member States of the European Pharmacopoeia Convention (36 countries) as well as by other countries, * easing of the management of applications for marketing authorization (MAA) for medicinal products in these countries, * Simplifies the approbation of a medicinal product compared to the active substance master file (ASMF) or European drug master file (EDMF). * Recognized by the following countries and institutions: - US (FDA), - Canada (HPFB), - Australia (TGA), - New Zealand, - Tunisia and Morocco. * Simplifies the trading with pharmaceutical substances and ingredients. WHERE TO CHECK WHO HAS ALREADY AN CEP? Website of the EDQM - The list of CEP granted is updated daily in the Certification Database. Information is given concerning name of substance, full CEP number, issue date of current CEP, status and type. HOW TO APPLY AND FEES Applications are submitted in electronic versions (e-CDT) to the EDQM .More information, please read guidance for submission Following documentation is required: - a complete application form including the fee form, - a single copy of a dossier in CTD format, - a copy of the Quality Overall Summary Fees - for new single applications about 3000 $, - for revision of a existing CED 500 $ (simple notification). HOW DOES THE PROCESS OF EVALUATION BY THE EDQM WORK? Application is sent to the Certification Division of the EDQM, it is validated and listed for assessment, EDQM may send queries to the applicant. when the queries have been resolved EDQM sends the applicant the CEP. QUERIES IN CEP? 1. IMPURITY PROFILE, the important cause of rejection of most CEP. CEP should describe the Impurity profile in detail as Potential Impurities in API, Residual Solvent Impurity arising from route of synthesis. If the starting material has carry forward impurity , it should justify that the API is free from it. 2. Latest Monograph of EP Your CEP should be as per the latest European Pharmacopoeia. HOW TO MAINTENANCE THE CEP? The holder of a CEP must inform the EDQM of any change(s) in the information provided in the certification dossier by sending all the necessary documents. A CEP is valid for 5 years from the date of first issuing. CEP is renewed only once and then valid for an unlimited period unless it is decided by the EDQM and upon justified grounds, to request one additional renewal. This policy applies to all CEP's for which the date of renewal is from 1 January 2006. For those CEP's, which have already been renewed, a new renewal is not necessary provided the dossier is in compliance with the current legislation. More information: PA/PH/ExpCep/T (04) 18 2R'