Biopharma – Europe, USA and Asia Regulatory News, Dec 2022

EU

ICH M12 on drug interaction studies – Scientific guideline

This guideline provides recommendation to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical pharmacokinetic drug-drug interaction (DDI) studies during the development of a therapeutic product. These aspects in general apply to the development of small chemical molecules.

EMA starts first real-world evidence studies under DARWIN EU

The European Medicines Agency (EMA) has begun the first real-world evidence (RWE) studies under its DARWIN EU initiative, kicking off three projects at the start of the “rapid ramp-up” of a program intended to support regulatory decision making. DARWIN (Data Analysis and Real World Interrogation Network) EU is designed to give EMA, the European Commission and national competent authorities in the 27 member states access to the results of analyses of real-world healthcare databases. EMA named Erasmus University Medical Center Rotterdam as the DARWIN EU coordination center in February.

EMA Safety Committee Recommends Pulling Cough Meds from EU Market

The European Medicines Agency (EMA)’s safety committee has recommended withdrawing medications containing pholcodine, an opioid active ingredient used alone or in combination with other substances, to treat dry cough, cold and flu symptoms.

USA

FDA Adopts ICH E19 Guideline on Selective Safety Data Collection

Reducing the collection of safety data in late-stage and postapproval clinical trials can improve trial efficiency, the FDA says in a final guidance published on Dec 5, 2022.

ICH Signals All Systems Go for Continuous Manufacturing

A new guideline from the International Council for Harmonization (ICH) promotes the use of a continuous manufacturing (CM) process that can lead to shorter production times, a reduced risk of human error and an increase in quality.

FDA Offers Guidance on Bioequivalence Studies, Pre-submission Correspondence

Sponsors hoping to use equivalence criteria in analyzing bioequivalence (BE) studies for their drug applications just got more details on how the FDA wants them to undertake that.

FDA updates statistical approaches for assessing bioequivalence

The US Food and Drug Administration (FDA) has published a draft guidance updating its principles for assessing in vivo or in vitro bioequivalence studies (BE) for investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs) and supplements to these applications. The update replaces a previous version in February 2001 and adds new topics such as assessing the bioequivalence for narrow therapeutic index (NTI) drugs and highly variable drugs, using adaptive trial designs, and statistical approaches for filling in missing patient data.

FDA revises ANDA facility correspondence draft guidance

The US Food and Drug Administration (FDA) on Friday revised its draft guidance on submitting pre-submission facility correspondence (PFC) for generic drug applicants seeking a priority review of their abbreviated new drug application (ANDA), prior approval supplement (PAS) or an amendment to either submission type in line with the Generic Drug User Fee Amendment (GDUFA III) program. The process can be used by generic drug sponsors to get a priority review goal date for their submission, but the PFC must be submitted two months before they submit their premarket application.

FDA official pushes for cloud-based regulatory assessments

A top US Food and Drug Administration (FDA) official touted the benefits of cloud-based regulatory submissions in ensuring consistent product reviews and explained how the agency is moving towards this platform through ongoing internal and international harmonization initiatives at a 30 November symposium on drug master files (DMFs) and structured data submissions. Lawrence Yu, director of the Office of New Drug Products (ONDP) in the Pharmaceutical Quality (OPQ) at the Center for Drug Evaluation and Research, and other agency officials discussed efforts to modernize the regulatory submission process. Yu is also the rapporteur of the International Council of Harmonisation’s (ICH) M4Q(R2) expert working group tasked with modernizing quality information that is submitted in the common technical document (CTD).

Industry asks FDA to harmonize pediatric study pharmacology guidance with ICH

Industry groups have asked the US Food and Drug Administration (FDA) to align its recently re-drafted guidance on pediatric clinical pharmacology studies with international guidance, as well as other FDA guidances. The groups also asked for more clarity on several aspects of the guidance. In September, FDA published a revised draft guidance on pediatric studies that drug and biologic sponsors can use to support their products. Several stakeholders, including the drug industry group PhRMA and Biotechnology Innovation Organization (BIO), wrote to the agency with their recommendations.

Guidance Clarifies How to Handle Aluminum Levels in Parenteral Nutrition Products

Manufacturers of parenteral nutrition (PN) products should determine the amount of aluminum in small-volume parenterals (SVP) as well as large-volume parenterals (LVP) to ensure PN products do not exceed the recommended daily limit, according to a new FDA draft guidance that clarifies key factors in determining the aluminum content in SVPs.

FDA Proposes More Detailed Annual Reporting for INDs

The FDA has issued two proposed rules on investigational new drug applications (IND) that would require more detailed IND reports and exemptions for clinical trials for drug uses of a food, dietary supplement or cosmetic product.

Asia

Applying for the import of unregistered medicines and biomaterials through the State Services portal in Russia

Legal entities will be able to apply for the import of unregistered medicines and biomaterials through the State Services portal, which will greatly simplify and speed up the process. The Unified Portal of State and Municipal Services contains an electronic form for submitting an application for the issuance of conclusions for the import into the Russian Federation of a specific batch of registered and unregistered medicines. An electronic application form can also be used when it comes to conducting clinical trials or drug evaluations. It is also possible to remotely obtain permits for the import into and export from Russia of biological materials obtained during a clinical trial of a medicinal product for medical use.

All Importers and local manufacturers of Srilanka

All importers and local manufacturers are requested to provide the hard copy of Maximum Retail Prices (MRPP) of medicines imported / manufactured by you as at 01.12.2022 within two weeks to pricing unit of NMRA with soft copy by emailing to pricing@nmra.gov.lk