REGULATORY SERVICES (Drugs)
Medwisdom, recognises that a regulatory submission is a means to an end, and not an end in itself. The aim is a successful marketing authorisation, and this requires efficient and appropriate responses to agency questions and objections. Our team is often called in to help at this crucial stage of the review process, providing input on the interpretation of questions, understanding the additional documentation that will be required and the way it needs to be presented in a response package.
CTD (Common Technical Document):
As per ICH, The CTD is organized into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions (ICH). In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to the FDA, US.
Now, CTD is mandatory for filling of drug application (Investigational New Drug, New Drug, Generic Drug) for almost countries. The Organisation Including the Granularity document should be as per ICH M4. Through ICH process, the CTD’s guidance have been developed for Japan, European Union, and United States. Almost Most of the countries have adopted the CTD format.
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG).
ACTD (ASEAN Common Technical Dossier):
This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use.
Countries: Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, Viet Nam
EAC (East African Community)
The East African Community (EAC) is a regional inter-governmental organization of 6 Partner States: the Republics of Burundi, Kenya, Rwanda, South Sudan, the United Republic of Tanzania, and the Republic of Uganda, with its headquarters in Arusha, Tanzania.
The format of dossier for drug application for above countries should be as per guideline listed down inline with guideline “Compendium of Medicines Evaluation and Registration for Medicine Regulation Harmonization in The East African Community (DOCUMENT NO: EAC/TF-MED/MER/FD/COM/N1)”
Dossier as per country specific guideline:
Some of countries having its own guideline for drug application dossier content. The nature and content of dossier are almost but the format is different.
Once approval has been obtained, there is usually a need for variations on the original marketing authorisation, introducing process scale-up, changing details in the product characteristics, adding new dosage strengths of the product, or new presentations, introducing new manufacturing facilities, applying for additional indications, and so forth. Moreover, a marketing authorisation requires continuous monitoring, in order to ensure that the conditions of the approval are being met, for example in the area of responding to ongoing questions that were not answered pre-approval. In some cases, we have continued to work on products that were originally approved with our involvement more than 18 years ago. In such cases, XYZ provides continuity in understanding how the product and the process has evolved over that period of time, providing input on the strategy and timing of future variations, and supporting the client in obtaining agreement with the relevant regulatory authorities on the strategy for changes.
Our services relating to post-approval issues include:
- Development of strategies for post-approval variations to the marketing authorisation, notably:
- Changes to manufacturing facilities or the process
- Changes to product characteristics or presentation of the product
- Extensions of shelf-life
- Introduction of additional indications to the original marketing authorisation
- Monitoring of post-approval commitments and responses to ongoing questions
- Organisation of post-approval meetings with regulators to address future issues in product development
- Discussion of variation strategies and timing with regulatory authorities
- Compilation and submission of responses to ongoing commitments, and variation dossiers