The end of October is coming. While many of us prepare Halloween decorations and stock up on candies, regulatory experts, mainly involved in the field of respiratory tract diseases, must not forget that 30/10/2024 is the deadline for submission of commentst the EMA Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD). More details on the EMA website.
Every time EMA releases a draft of a new or revised guideline, stakeholders and public members are encouraged to submit their comments. Comments received during the consultation process are considered while preparing the final version of the guideline. Therefore, it is a valuable opportunity to impact the regulatory requirements before they come into force. Then, why don’t you check which guidelines are currently under consultation? The list of EMA’s open public consultations can be found here. At SciencePharma, we are always up to date with the newest guidelines and we don’t hesitate to submit our comments to EMA whenever possible.
Why do the guidelines change?
They evolve with scientific progress and the experience of regulatory bodies with a given type of product. Such is the case with the OIP guideline. The most significant proposed changes to the guideline include:
- using studies with pharmacodynamic or clinical endpoints is now not recommended to demonstrate therapeutic equivalence in general – a pharmacokinetic (PK) study is then far more important;
- more guidance on the design of the PK study are offered, including the possibility of using early partial AUC as a surrogate for efficacy in PK study;
- in the aerodynamic particle size deposition (APSD) studies, the requirements for stage grouping are specified in more detail;
- requirements for extrapolation of PK data from adults on children have been simplified as the same age limits as for the reference product are now accepted in many cases.
Do you agree with the changes implemented in the OIP guideline? If you are involved in developing OIP products and want to take part in creating a regulatory environment in this field, remember to submit your comments to EMA.