Pharma/Biotech – USA, Europe Regulatory News, Sept 2023 Vol. 1

USA

Guidance’s Released on EPCIS Standard for DSCSA Compliance, Pulmonary Disease Drug Development

The FDA recommends that “trading partners” use the Electronic Product Code Information Services (EPCIS) standard developed by GS1 for compliance with the Drug Supply Chain Security Act (DSCSA) in a final guidance issued Tuesday.

Three FDA Guidance’s: Using Real-World Data in Observational Studies and DSCSA

The FDA issued three final guidance’s on Wednesday, one on the use of real-world data (RWD) in non-interventional (observational) studies and two on the Drug Supply Chain Security Act (DSCSA).

FDA to Delay Enforcement of DSCSA Requirements Until November 2024

The FDA “does not intend” to enforce the Drug Supply Chain Security Act (DSCSA) requirement that manufacturers electronically capture and share data that will track a drug at the individual package level from manufacture to sale until Nov. 27, 2024 the agency announced in a guidance published on Friday.

FDA Issues Product-Specific Guidelines for Generic Drug Development

The FDA has issued multiple draft and revised product-specific guidance’s that provide recommendations on the design of bioequivalence studies to support ANDAs and facilitate generic drug product availability.

FDA Finalizes Guidance on Informed Consent Process

After nine years in draft form and 127 comments received from stakeholders, the FDA has finalized its guidance on informed consent, adding a question-and-answer section that addresses specific issues.

Untangling Combination Product Regulations Requires More FDA Guidance

The complex process of regulating combination products begins with the FDA’s determination of which center CDRH, CBER or CDER will take the lead role in overseeing a product’s development, but even after that determination is made, the way regulations are applied opens up another layer of complexity. “At a high level,” says Bradley Thompson, an attorney at Epstein Becker Green, “the biggest problem the industry faces is that there simply aren’t enough FDA guidance documents that explain the rules with regard to combination products.” Because of how much more labor-intensive it is to have the centers work together, he said, “they do not often come up with guidance to help combination product developers,” leaving combination product developers “guessing.”

Classification Categories, Formal Meetings Under BsUFA III Explained in Draft Guidance’s

Two draft guidance’s with the FDA’s recommendations for Biosimilar User Fee Act (BsUFA III) classification categories and preparation for formal meetings with agency staff were issued today.

Balance Benefits, Risks of Collecting Diverse Patient Data Post-Approval, Guidance Says

Acknowledging that collecting diverse patient data prior to drug approval is not always feasible, the FDA has published draft guidance that gives direction on gathering underrepresented population data in the post-market setting.

Industry Objects to “Stacking” Requirement in Medicaid Drug Rebate Rule

The big three drug associations, representing brand pharmaceuticals, generics and biotechnology, have all expressed strong objections to the CMS proposed rule for the Medicaid Drug Rebate program “stacking” requirement that revises the definition of “best price.”

FDA issues draft guidance on post-warning letter meetings under GDUFA III

The US Food and Drug Administration (FDA) has published a new draft guidance to help sponsors navigate the post-warning letter meeting process as specified under the latest round of the Generic Drug User Fee Amendments (GDUFA III). The guidance spells out the process for how an eligible facility may request a post-warning letter meeting with FDA, regarding what corrective action the facility is taking to address current good manufacturing practice (cGMP) deficiencies described in the warning letter, how to prepare and submit a complete meeting package and how FDA will conduct the post-warning letter meeting.

FDA and EMA Publish Guidance on Nitrosamines

The FDA and the European Medicines Agency (EMA) have both issued guidance’s on various aspects of detecting, measuring, limiting and avoiding the presence of nitrosamine impurities in pharmaceuticals. The FDA’s guidance, “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs),” provides drug manufacturers and applicants with a recommended framework for a risk-based safety assessment of NDSRIs that could be present in approved and marketed drug products, as well as products under review by the FDA.

Drug Supply Chain Act Readiness Prompts FDA Guidance and House Lawmaker Letter

The FDA has released a final guidance spelling out when and how drug makers may seek a waiver, exception or exemption from its regulations as permitted by the Drug Supply Chain Security Act (DSCSA) while a bipartisan group of House lawmakers is pressing the FDA on whether the industry is prepared for the final stage of the act’s implementation. The DSCSA mandates that by November 27 manufacturers electronically capture and share data that will track a drug at the individual package level from manufacture to sale.

FDA/DEA Letter Asks ADHD Drug makers to Increase Production

The FDA and the Drug Enforcement Agency (DEA) have asked manufacturers to confirm they are working to increase production of their allotted quota of ADHD drugs to help resolve shortages. In an Aug. 1 letter addressed to “Americans”, the FDA and DEA explained the steps they are taking to mitigate shortages of stimulant medications. “We are calling on key stakeholders, including manufacturers, distributors, pharmacies, and payers, to do all they can to ensure access for patients when a medication is appropriately prescribed,” the agencies wrote.

Breaking Down the Draft of ICH E6(R3)

In the third revision to its guideline on good clinical practice, ICH E6, the International Council on Harmonization (ICH) is proposing a full-scale restructuring of the document that has provided a global standard for sponsors, sites and investigators since 1996. In this blog post from Avoca, a WCG company, Karen Harvey, senior director of the Avoca Quality Consortium, outlines the changes in the new ICH draft guideline.

FDA publishes additional guidance’s on delay of enforcing DSCSA electronic tracking requirements

The US Food and Drug Administration (FDA) published two additional guidance’s with immediate effect that provide more details for trading partners on the one-year extension from enforcement of requirements for tracking products electronically under the Drug Supply Chain Security Act (DSCSA). A final guidance concerning the agency’s compliance policies of enhanced drug distribution security requirements was also recently published and intended for trading partners such as manufacturers, wholesale distributors, dispensers, repackagers and other stakeholders who are subject to DSCSA.

EUROPE

Frequently asked questions about parallel distribution

EMA updated Frequently asked questions about parallel distribution. What to do when my organization details have changed? What is the validity of the notice for parallel distribution and can it be revoked, suspended or annulled? What is the scope of and how to submit a bulk change? Were updated.

Paving the way towards coordinated clinical trials in public health emergencies in the EU

EMA has published a report from a workshop that collected insights and suggestions for possible EU-level actions to improve the way clinical trials are set up and conducted in the European Union (EU) during public health emergencies. The actions presented in the report aim to holistically address the barriers and challenges experienced during the COVID-19 pandemic and the outbreak of Mpox disease in setting up adequately sized clinical trials across multiple Member States that enable rapid gathering of sufficient, high-quality evidence to support robust decision-making by health authorities across the EU.

How to prepare and review a summary of product characteristics

EMA updated How to prepare and review a summary of product characteristics. The committee for human medicines (CHMP) has adopted guidance for assessors to follow a consistent approach in the process of defining therapeutic indications during the assessment of centralized applications for new active substances or new indications. When is it relevant to include a bodyweight limit in the wording of a pediatric indication? is updated.

Risk management plans

EMA updated Risk management plans. From 20 October 2023, EMA is publishing RMPs (main body and annexes 4 and 6) for all centrally authorized products: initial evaluations; RMP updates. EMA no longer publishes RMP summaries from the same date. The aim is to increase transparency of the safety review process for all centrally authorized products. The RMP or RMP summary is available on each medicine page.

Q&A: Good clinical practice (GCP)

EMA published Q&A: Good clinical practice (GCP). What are the expectations for distribution of updated Investigator’s Brochures (IBs) and updated Informed Consent Forms (ICFs) to clinical sites/ investigators? were updated.

Guidance to applicants /Marketing Authorization Holders (MAHs) on oral explanations at EMA

EMA updated Guidance to applicants /Marketing Authorization Holders (MAHs) on oral explanations at EMA. This document is intended to provide practical guidance to companies on oral explanations/discussion meetings before Committees, Working Parties, Scientific Advisory Groups (SAGs) and Ad Hoc Expert Groups (AHEGs) (irrespective of the type of application / procedure under discussion).