November 23, 2022 Pharma Regulatory Updates

BioPharma – USA/Europe Regulatory Updates, Week 2 Nov 2022

Europe (EU)

EMA consults on planned update to computerized systems annex of GMP guide

The European Medicines Agency (EMA) is seeking feedback on the planned revision of the good manufacturing practice (GMP) annex on computerized systems. The agency wants to revise the existing text, which dates to 2011, because it “does not give sufficient guidance within a number of areas.” “The current Annex 11 does not give sufficient guidance within a number of areas already covered, and other areas, which are becoming increasingly important to GMP, are not covered at all. The revised text will expand the guidance given in the document and embrace the application of new technologies which have gained momentum since the release of the existing version,” according to the paper.

Document of instructions of the Spanish Agency of Medicines and Health Products for carrying out clinical trials in Spain

In this instruction document of the Spanish Agency for Medicines and Health Products (hereinafter AEMPS) for the realization of clinical trials in Spain is provided, in a format of questions and answers, information on the practical aspects involved in the application of the new royal decree highlighting the changes with respect to the previous royal decree.This document aims to cover those aspects that the Royal Decree1090/2015, of December 4, leaves the development of instructions by the AEMPS, as well as any other that requires clarification.

UK Allows Interchangeability of Biosimilars

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said it will allow the interchangeability of biosimilars, in a final guidance that adopts a similar approach to that taken earlier this year by the European Medicines Agency. Once authorized, a biosimilar product is interchangeable with the reference product, which means a prescriber can choose the biosimilar medicine over the reference product and expect to achieve the same therapeutic effect, the agency said. All biological medicines, including biosimilars, should be prescribed by brand name, MHRA said, adding that substitution at the pharmacy level without consulting the prescriber is not permitted for biological medicines, including biosimilars

EMA human medicines committee (CHMP) highlights, November 2022

The Committee for Medicinal Products for Human Use (CHMP)’s November meeting consisted of approval recommendations for four medicines, including a biosimilar for osteoporosis and a new COVID-19 vaccine. VidPrevtyn Beta, recommended as a new recombinant, adjuvanted booster COVID-19 vaccine in adults previously vaccinated with an mRNA or adenoviral vector COVID-19 vaccine. The committee adopted a positive opinion for Kauliv (teriparatide). New generic medicine Pirfenidone Viatris (pirfenidone), received a positive opinion to treat idiopathic pulmonary fibrosis (IPF), .Sugammadex Amomed (sugammadex) was given a positive opinion by the CHMP for helping to reverse neuromuscular blockade induced by muscle relaxants rocuronium in adults and children or vecuronium in adults.

Particle Works launches automated platform for LNP formulation screening

Particle Works launches its second platform, the Automated Library Synthesis (ALiS) System, enabling automation and high-throughput screening of lipid nanoparticle (LNP) formulations and mRNA candidates in early-stage drug development. Particle Works have introduced a platform to increase lab efficiency while retaining the consistency, monodispersity and high encapsulation efficiency. The ALiS platform, based on microfluidic technology, features dedicated software for walk-away processing of up to 96 unique formulations in a working day.

Changes to the Guidance document Variations TAM HMV4

A new reporting time limit of 60 days applies to variations without assessment. The reporting time limit for variations without assessment has been extended at the request of marketing authorisation holders: instead of the previous 30 days, a reporting time limit of 60 days now applies. The revised Guidance document Variations TAM HMV4 is valid with effect from 1 November 2022.


FDA official: Most drug GMP warning letters in FY2022 stemmed from onsite inspections

A US Food and Drug Administration (FDA) official said that most warning letters issued for drug good manufacturing practice (GMP) issues in fiscal year 2022 were the result of onsite inspections, reversing a pandemic-era trend of enforcement actions triggered by the use of alternative tools. Yet the agency faces “incredible challenges” going forward, as it tackles a backlog of inspections that were put on hold during the pandemic, asserted Jeffrey Meng, program division director, Division of Pharmaceutical Quality Operations III, Office of Regulatory Affairs, who provided an update on compliance activities at the PharmaLink conference hosted by the Regulatory Affairs Professionals Society (RAPS) and the Association of Food and Drug Officials (AFDO).

Stakeholders ask FDA to harmonize adverse events terms with standards orgs

Pharmaceutical companies are asking the US Food and Drug Administration (FDA) for more adverse events reporting standardization by harmonizing with standards organizations as well as further clarity around key terms. Their comments are in response to a recent workshop on the topic and documents released by the agency. Lack of standardization of safety data analysis and visualization, as well as inconsistencies in how adverse events are defined, categorized, analyzed, and presented in marketing applications, has led to concerns about whether safety data is being accurately presented, according to FDA. That concern prompted the Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND) to develop two documents on the topic.

Drug preclusion and public health: The case for a narrow interpretation of ‘article’

The definition of “dietary supplement” in the Food, Drug, and Cosmetic (FD&C) Act includes several provisions limiting what can be a legal dietary supplement based on the ingredients used and delivery form, as well as whether a substance has a history of drug use. This article explores the US Food and Drug Administration’s (FDA’s) use of this last provision, often called “drug preclusion.” The authors examine the history of the provision, Congress’s purported purpose for inclusion in the definition of “dietary supplement,” how it has been interpreted over the years, and concerns that an overly broad interpretation harms both businesses and consumers.

FDA official offers insights on Emerging Technology Program

The US Food and Drug Administration (FDA) accepts a wide variety of applications into its Emerging Technologies Program (ETP), and is not just focused on continuous manufacturing, said Joel Welch, associate director for science and biosimilar strategy in the agency’s Office of Biotechnology Products.

“I think that sometimes there is a misperception that advanced manufacturing is just about continuous manufacturing,” said Welch who provided an update on the ETP at the recent PharmaLink conference hosted by the Regulatory Affairs Professionals Society (RAPS) and the Association of Food and Drug Officials (AFDO). He added that, “In reality, advanced manufacturing certainly includes continuous manufacturing, but it is much more than just that.” Advanced manufacturing can include novel manufacturing methods to improve process robustness, novel dosage forms, new modeling tools for analytical testing and novel container closure systems.

FDA Pushes Back Comment Period on IRB, Informed Consent Rules Until End of Year

In response to requests for a later deadline, the FDA has granted more time to comment on a pair of long-awaited proposed rules on institutional review board (IRB) reviews and informed consent requirements for clinical trials, pushing back the deadline until Dec. 28.

DOJ Rejects Florida’s Claim FDA is Stalling on Drug Imports From Canada

The Biden administration has asked a federal judge to dismiss claims that the FDA has intentionally delayed rendering a decision on a Florida proposal to import prescription drugs from Canada.

FDA sees room for growth for complex generics

The complex generic market needs to “achieve parity” with the innovator market, as the number of approvals is lagging the innovator sector and has not achieved its full market potential, said Robert Lionberger, director of the US Food and Drug Administration’s (FDA) Office of Research and Standards in the Office of Generic Drugs (OGD). While 25% of all approved reference listed drugs (RLDs) are deemed complex products, only 13% of all generic drugs approvals in FY 2022 had this distinction. A product is considered complex if it has a complex active ingredient, such as a peptide or polymeric compound; is a complex formulation; has a complex route of delivery; or has a complex dosage form, such as a transdermal patch, a metered dose inhaler or an extended release injectable.

FTC files amicus brief challenging REMS patent listings in FDA’s Orange Book

The US Federal Trade Commission (FTC) has filed an amicus brief in US District Court in Delaware arguing against listing patents on pharmaceutical distribution systems in the Food and Drug Administration’s (FDA) Orange Book.The amicus brief relates to the case of Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals, an ongoing legal battle in which Jazz is alleging that Avadel infringed on its patent for the distribution system of the narcolepsy drug Xyrem under a risk evaluation and mitigation strategy (REMS). Avadel is seeking FDA approval of its own narcolepsy drug, Lumryz, and is countersuing Jazz in an effort to delist the Xyrem distribution patent (known as the ’963 patent) from the Orange Book on the basis that it does not claim Xyrem or a method for using it. In the meantime, the patent infringement suit triggered a 30-month stay on FDA’s approval of Lumryz under the Hatch-Waxman framework.

FDA Publishes MAPP on Quality Assessment for Products in Expedited Programs

The FDA offers detailed information on the regulatory flexibilities it offers to drug makers that have products in expedited programs to help them overcome chemistry, manufacturing and controls (CMC) in a Manual of Policies and Procedures (MAPP) released yesterday.

FDA Seeks Comment on ICH Draft Guidance on Viral Safety of Biotechnology Products

The FDA is seeking public comment on an International Council for Harmonisation (ICH) draft guidance that describes risk-based principles and mitigation strategies to assure viral safety in biotechnology products from cell lines.

FDA’s Onsite Drug Inspections Ramped Up in Fiscal 2022, Says ORA Official

After the challenges of global in-person facility inspections throughout the pandemic, the FDA is at the start of “a return to a steady state,” of onsite work, said an FDA assistant commissioner in the keynote address at the WCG-FDA news’ 17th Annual Inspections Summit in Washington, D.C., on Thursday.

Industry Coalition Pushes Congress to Tackle Threat of Antimicrobial Resistance

More than 150 industry organizations and drug makers have submitted a letter to Congressional leaders urging passage of the Pasteur Act, a languishing bill first introduced in 2020 to incentivize development of new treatments for combating drug-resistant pathogens.

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