With ICH Q12 in process, industry and regulators around the world are taking a hard look at: ● the current post-approval change regulatory quagmire ● what a more efficient, scientifically-based, review/inspection coherent, and process improvement and product supply friendly lifecycle management paradigm would look like, and ● how the international community could harmonize and share resources around it. IPQ departs from the usual Monthly Update format to provide a series of stories exploring the various dimensions of the product lifecycle regulatory challenge and the international effort to better address it.
The first in the series focuses squarely on the ICH Q12 initiative and the discussions the Expert Working Group (EWG) members are engaged in to shape the guideline in a way that achieves the desired objectives. Included is a review of a two-day meeting on Q12 held at EMA headquarters in London in late October and the impact of the discussions on the EWG’s members. The concept of “established conditions” is emerging as pivotal, and the EWG is wrestling with the challenge of defining how the concept should interrelate with the other components of the lifecycle management regulatory process. The story also includes insights on the Q12 development process by EWG PhRMA rep Mary Oates (Pfizer) and an update on its progress by industry rapporteur Moheb Nasr (GSK).
In the second story, IPQ reviews the dialogue that took place at a panel session on Q12 held at the Generic Pharmaceutical Association’s Fall Technical Conference in November about the positive impact that the broadening of the EWG participation base is having on the guideline’s development and its potential to get more global traction.
With the Q12 initiative as a catalyst, strong light is being shed on the full dimension of the current post-approval change problem and the stakes in finding an international approach with enough power to address it. The third story in this Monthly Update takes a look at the resource drain and lost opportunity caused by the current situation from the vantage point of a pair of industry experts in regulatory affairs and quality systems, respectively. Their testimonies on the effort it takes to make changes in the face of the regulatory complexities and constraints that manufacturers face globally, which were provided at a recent PDA workshop, are compelling.
The issue then explores what the workshop participants had to say about moving the pharma quality regulatory paradigm in the direction of universally agreed to and audited standards and away from a system based on one-off negotiations between companies and reviewers at individual agencies. Standardized global change protocols that would build off the positive experience companies have had in the US with the use of protocols for making the same changes to multiple products was among the proposals.
Rounding out the series are a pair of stories on the ongoing efforts among the agencies in Latin America to advance their processes for regulating biotech products.
In focus are the presentations and discussions that took place at the 2015 CMC Strategy Forum held in Brasilia at which representatives of the key Latin American regulatory agencies, FDA and EMA met with industry experts to explore how the biopharma regulatory capacities in the region have been evolving and where the opportunities for further strengthening lie.
The first of the two stories reviews the insights that emerged at the opening regulatory session on why convergence, transparency, predictability and training, supported by international cooperative processes, are critical to drive this advancement. The story also explores the dialogue that took place at the separate forum sessions that followed on the technical CMC challenges presented in the biotech arena by: ● the characterization, control and regulation of protein glycosylation ● cold chain management and product transportation qualification, and ● technology transfer. [A more in-depth review of the discussions at the forum around global site and analytical method transfers, in particular, are provided in IPQ’s Monthly Update for September.]
The focus narrows in the second of the pair onto the presentation and discussions at the opening forum session on what the meta-association Latin America Federation of the Pharmaceutical Industry (FIFARMA) views as the priorities for improving biologics regulation in the region. An urgent need, FIFARMA stressed, is to extend the progress made on the approval side to fill the current gaps for product lifecycle management. Representing the federation, Roche’s Thomas Schreitmueller explained why a commonly adopted risk-based approach for post-approval change regulation is important and what the pathway to achieve it looks like. The dialogue that took place at the forum is revealing of the challenges that will be on the table in implementing ICH Q12 globally.
Included are three dozen “Updates in Brief” on breaking developments, with links to all the documents referenced and to our related in-depth stories. Also in the issue is a full listing of the drug GMP warning letters and recalls posted by FDA during November and December.
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