Basically, every medicinal product application for marketing authorization needs to be submitted with registration dossier in Common Technical Document (CTD) structure consisting of Modules 1-5. Module 3 of CTD refers to quality part. It covers relevant chemical and pharmaceutical information about the QUALITY of medicinal product, its active substances and excipients (including data for biological/biotechnological products). It provides the detailed information on formulation, manufacturing process, relevant controls and other important product quality data needed to be assessed by Agencies prior granting the marketing authorization.
The quality of a medicinal product must be proven according to the current scientific knowledge and respective guidelines. There is a long list of regulations aimed to assure that the product is designed with highest quality in mind. The specific regulatory requirements depend on many aspects, like the dosage form (solid, liquid), administration route (oral, parenteral, topical, inhalation), presence of the dosage device (syringes, pens, cups, sprays), target population (children, adults, elderly people), substance type (known, pharmacopoeial or novel) and substance origin (chemical, herbal, biological, biotechnological, genetically engineered, immunological, radioactive), etc.
Notice to Applicants (NTA), Volume 2B-CTD indicates the scope of the guidelines regarding the quality of medicinal products and provides the respective references to assist applicants. As part of CTD, Module 3 should take into account the relevant information described in existing EMA (European Medicines Agency) guidelines and where relevant, also additional guidelines listed in the NTA. It is also of key importance to follow the requirements of the European Pharmacopoeia wherever they apply.
It is worth remembering, as also highlighted in the NTA, that the content of NTA sections which refer to Module 3 is intended to be illustrative only and should not be considered an exhaustive source of guidance. It is the Applicant’s responsibility to ensure that all relevant provisions, guidance, requirements and current scientific knowledge are taken into account. This is often a challenge for Applicants to go through the thicket of quality requirements, but ultimately benefit patients.
If you find yourself asking following questions, we are here to help:
If you are overwhelmed by the plethora of various guidelines and still wonder if the quality of your medicinal product-to-be is sufficient for the registration (e.g. have all the needed experimental data, have enough validation or properly designed stability studies), you’re welcome to contact us.
At SciencePharma we have dozens of Experts and years of practical experience. We follow guideline updates. We have seen hundreds of dossiers in multiple registration procedures and countries of documentations for probably all product types, from tablets, through syrups to parenterals, chemical, biological or even advanced medicinal products. We have registered multiple products all over the world and we’ve managed many challenges that dossiers may face. We have the knowledge and experience to help you assess whether a given dossier is sufficient for EU procedures on national and international level (decentralised procedure (DCP), mutual recognition procedure (MRP), central. We can perform Module 3 audit to demonstrate what is missing which can cause further Expert questions. At SciencePharma we do also advise during registration process to help you answer the questions arisen.
With multiple Experts on board, with broad and strong scientific background, with the knowledge of current guidelines, and yet thinking out-of-a-box, we have a team capable of thoroughly assessing the quality of your medicinal product to enable smoother registration process.
Would you like to register a product based on a documentation you want to buy, but you’re not sure if it is of sufficient quality? Would you like to assess your own documentation prior registration procedures?