ANVISA has just published the guide for preparing registration dossiers in CTD format and some may be asking themselves: what now? Is everything I learned worthless?
But what does CTD mean?
It stands for Common Technical Document and it is a model for the presentation of new dossiers for registration of medicines that was agreed between the health authorities of the United States, Europe and Japan in 2003, but which today is already adopted by many other countries like Canada and Australia.
The CTD is maintained by the ICH (International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical Products for Human Use). Brazil is a member of this group and is committed to adopting it until 11/2021. Therefore, in this first moment, the adoption of the CTD format by companies is optional.
The CTD format is divided into 5 parts and in a very summarized and superficial way I will make the parallel with what we have today:
Module 1 - Administrative: Administrative information, petition forms, Certificate of Good Manufacturing Practices, package leaflet and labeling.
Module 2 - General Summary of Quality: this is a totally new module and with which we will have to familiarize ourselves, as here are presented the summaries, critical and rational points of each of the quality modules, pre-clinical and clinical.
Module 3 - Quality: (pharmaceutical documentation): here we present what we understand today as Documentation on the active pharmaceutical ingredient, Quality control of excipients, Quality control of packaging material, Technical report on the development of the formulation, Quality control of the Finished Product, Stability Studies, etc.
Module 4 - Pre-Clinical (Pharmacology / Toxicology): for new products in this module, the results of pre-clinical studies are presented.
Module 5 - Clinic - efficacy and safety (Clinical Trials): this module presents the equivalent of our Efficacy and Safety Report for new / innovative drugs or the bioequivalence report for generics and similar.
At first it can be a little scary, but rest assured, if we look back we will see how much progress we have made since the introduction of generics in Brazil, when we made the first big leap towards equalization with international drug registration standards.
At the time, it was also very challenging to leave a mere collection of documents such as a petition form, package insert and a simplistic technical report to develop products that were bioequivalent with a dissolution profile, in addition to performing Pharmaceutical Equivalence and the dreaded bioequivalence. It hurt a little, adaptation and commitment were necessary, but in the end it contributes a lot to the growth of the Brazilian pharmaceutical industries.
Today we are much more prepared than in the past, considering we have a solid base and know how to develop medicines with the same pillars and international technologies. What we will have to learn is to put it in a different model, because practically everything that is requested in the CTD format is already done for the dossier in the current format.
Certainly, it is a challenge. But it is also a great opportunity, because just like generics brought a great wave of development and prosperity to national industries, the CTD format opens an enormous window of opportunity towards the internationalization of medicines manufactured in Brazil.