ProPharma Group has a proven track record of delivering project management solutions for eCTD submissions, as well as in many other areas, including Regulatory, Quality, and IT.
Organizations that partner with experts on local and global regulations and requirements will gain a significant competitive edge on the way to a successful submission. Let us guide you through the eCTD process and partner with you to manage the multitude of requirements associated with success. We partner with pharmaceutical, biotechnology, and medical device clients to tackle complex challenges. Contact us to learn how our experienced team can help ensure regulatory and development success throughout the product lifecycle.
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For more details, check our Privacy Policy. Kristen Young. Advantages of the eCTD structure: Reviewers are already familiar with the content and document standards Local affiliates can review updates in real-time FDA reviewers can review faster and more efficiently, shortening time to approval Handling, managing, and archiving trial and document-essential information is less time-consuming Documents are easily accessible via search and tracking The risk of missing or duplicated documents is minimized Challenges of the eCTD Structure While most larger organizations have taken proactive measures to fully implement eCTD submissions, smaller companies may not have fully developed measures to ensure coordination of documents across the eCTD.
Below are 3 of the obstacles that companies may face in preparing for an electronic submission: Transitioning from paper to eCTD All organizations are now required to provide an electronic format for submissions; for smaller companies in various stages of submission planning, paper documents may still need to be converted into a digital format. Ensuring submission-readiness To successfully migrate to an electronic submission platform, companies must be equipped with cutting-edge tools such as: eCTD publishing software FDA fillable forms Electronic Submission Getaway ESG Viewing software Each tool requires some form of selection, setup, validation, compatibility checks, training, maintenance, and software upgrades.
Following guidance and directives for a successful submission Despite ICH guidance and FDA directives, errors and mishandling can occur, leading to rejection of a submission. The agency lists top 3 reasons for rejection: Use of duplicate sequence number Lack of consistency between eCTD backbone files and regulatory forms Lack of conformity with the published FDA Data Standards catalog If you lack in-house technical expertise, now is a good time to bring in outside support.
They contain for each document information such as title, subject described by the title given in the table of contents for this document , relationship with other documents, version information , location, submission. Submission in which the CTD information provided in support of the application is submitted in electronic form in accordance with the harmonized European recommendations for file formats and tables of contents.
This authority delivers marketing authorizations MA for medicines and health products for the European territory, for centralized procedures. Specific to the eCTD format , this dossier contains around ten pieces of structured information specific to the product and the application full name, applicant, regulatory activity, type of application, procedure number, etc.
Electronic submission in which the information provided in support of the application complies with the structure and file formats defined by EU NeeS. This type of application may be made only under certain conditions and otherwise must be made in eCTD format.
It is responsible for regulating food safety, tobacco products, dietary supplements, pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices and veterinary products. ICH International Conference aims to define the standards to be applied to the development of new drugs. It was created in by the regulatory authorities and pharmaceutical companies of the United States, the European Union and Japan.
It has published numerous guidelines to facilitate the harmonization of marketing authorization procedures for medicines. It is made to apply to the FDA for approval to conduct clinical trials of a new drug. The FDA has 30 days to review the application. The IND may be for commercial purposes or purely research. It contains information about:. When a main modification entails one or more other modifications, they are deemed to be linked.
All these modifications put together form a single regulatory activity and the modifications are submitted in one dossier. The applicant should justify that the modifications are linked. Submitting a Market Authorization Application is a mandatory prerequisite for the commercialization of a pharmaceutical product. Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:.
This procedure is mandatory for any drug already having an MAA and to be marketed in more than one Member State. The principle is the recognition by the concerned member states CMS of the marketing authorization granted by the reference member state RMS chosen by the firm.
Electronic submission for marketing authorization for which the data submitted meet the eCTD format , but for which the requirements are eased compared to the eCTD. Procedure by which a company seeks a marketing authorization directly to the authorities of a member state of the EU. This mainly concerns known active ingredients. Submission in which the CTD information provided in support of the application is submitted in the form of paper documents. PDF is a document description language created by Adobe Systems.
It helps preserve the formatting of the pages, regardless of the system used to view or print. Certifications and Memberships.
Partner Program. Contact us. The changes include the following points: the validation of eCTD submissions concerning errors found during content validation, electronic signatures, the re-baselining of a broken eCTD lifecycle, the structuring of the Module 3 Quality Folder, and the PSURs section.
Prepared by the Human Harmonisation Group page 16 2. Prepared by the Human Harmonisation Group page 17 3. Prepared by the Human Harmonisation Group page 25 3. Please note: If an existing eCTD is not structured in line with the given guidance, the dossier should be restructured with the next submission of a quality variation that affects the relevant content.
Prepared by the Human Harmonisation Group page 28 For further information, view the release notes or read the full updated guidance. It is important to note that there are a number of significant considerations in the event that the manufacturer decides to perform a lot-to-lot consistency clinical study to fulfil the requirements for vaccine licensure of an NRA.
Vaccines used in clinical-consistency trials must have been manufactured at commercial scale. The study should be designed and analysed as an equivalence trial and have a pre-defined criteria and choice of parameters to conclude comparability.
Changes to the batch size used to produce the clinical lots will require additional information to support the change for example, scale-up. Depending on the manufacturing consistency data, additional clinical studies to support comparability to the clinical lots may be required.
Assessment reports for both initial licensure and any subsequent variations to the licence for changes relevant to clinical data are requested. Provide an independent clinical expert report on the clinical studies evidence of expertise and independence should be provided.
If the application for prequalification is based on the extrapolation of the existing clinical data to the likely circumstances of use after prequalification, and if the data are old or there is a doubt regarding the ethical or regulatory oversight of the trial, the report should discuss the degree of compliance with WHO GCP recommendations and current guidance regarding preclinical and clinical trials with vaccines.
Safety data should be submitted both in the case of the initial application for prequalification evaluation and for reassessment purposes. Initial evaluation of vaccines that have been in the market for more than five years or reassessment of already prequalified vaccines. The latest PSUR may be provided. A judgment of seriousness and whether or not the event was expected in the light of the prescribing to the vaccine made by a clinician and, where relevant, by the applicant company or its independent clinical expert, should be included.
Add a cross reference to Module 5 and any studies that may not be part of the CTD.
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