MHRA updates biosimilar guidance to allow interchangeability between products

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its 2021 guidance on biosimilars to allow interchangeability between biosimilars if they use the same reference medicinal product (RP). On 6 November, the British regulatory agency updated a 2021 document titled Guidance on the licensing of biosimilar products. It has expanded the interchangeability section of the document to account for biosimilars that have the same RP.

EMA Guidance Sets Out Criteria, Process for Requesting Orphan Drug Designation

Before filing for an orphan medicinal product designation, says the European Medicines Agency (EMA) in a new guidance, sponsors should request a pre-submission meeting to discuss the prevalence of the rare disease, the scope of the application, the drug’s active substance and mode of action and supporting clinical and nonclinical data.

EMA encourages companies to submit type I variations for 2022 by end of November Share

The European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IA and type IAIN variations for 2022 no later than Wednesday, 30 November 2022. This will enable EMA to acknowledge the validity of the submissions before the Agency’s closure between 23 December 2022 and 3 January 2023 and within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.For procedural or regulatory queries related to these procedures for human medicines, marketing authorisation holders can raise a ticket via the EMA Service Desk, using the “Question” option. The Type of question to be selected is “Post-authorisation queries”, followed by sub-option “Variation IA” or “Variation IB A&B scopes” or “Variation IB C scopes”.

European Commission Decision Reliance Procedure (EC DRP) extension

European Commission Decision Reliance Procedure has been extended by 12 months to apply across Great Britain until 31 December 2023, to ensure British people continue to have timely access to medicines while MHRA develop proposals for a new international reliance framework.The launch of new medicines has long lead times and regulatory strategies are planned months or years in advance. To provide suitable timeframe for the right strategies to be developed that capitalise on the opportunities of being a sovereign regulator, the European Commission Decision Reliance Procedure (ECDRP) will be extended until 31 December 2023.

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 forMedicines and Health Products (hereinafter AEMPS) for the realizationof clinical trials in Spain is provided, in a format of questions andanswers, information on the practical aspects involved in the applicationof 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 bythe 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.

Changes to the Guidance document Variations TAM HMV4

Swissmedic published changes to the guidance document variations TAM HMV4. 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.

Deadlines for the submission of dossiers during end-of-year period

During the end-of-year period, the FAMHP will be closed from Monday 26 December 2022 through Friday 30 December 2022. Deadlines have been set for the submission of different types of dossiers. The validation procedure for phase I monocentric dossiers submitted after 13 December 2022, and the validation procedure for dossiers or assessment of responses to GNAs/RFIs submitted after 20 December 2022, will start on 9 January 2023. In addition, the applicants will receive a delay to provide their responses to GNAs/RFIs if the deadline to provide their responses would fall after 20 December 2022. This will be indicated in the GNA/RFI letter.

FDA officials discuss biosimilar inspections, BsUFA enhancements

A US Food and Drug Administration (FDA) official said that sites making biosimilars will be inspected in person, as opposed to virtual methods, as these products are relatively new and involve novel manufacturing processes. She also noted that the facilities making these products are generally new to biosimilar manufacturing. Jacqueline Corrigan-Curay, principal deputy center director for FDA’s Center for Drug Evaluation and Research (CDER), made the remarks at the Association for Accessible Medicines’ (AAM) GRx+Biosim conference in Bethesda, MD on Monday.

ANDAs Must Demonstrate “Sameness” of Active Ingredients, FDA Draft Guidance Says

Generic drugmakers are responsible for providing sufficient information in their abbreviated new drug applications (ANDA) to show that the generic drug’s active ingredient is the same as that of its reference listed drug (RLD), the FDA said in a draft guidance issued today.

High concordance in breakthrough therapy, PRIME decisions

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) agreed on nearly two-thirds of decisions to grant or deny requests for drugs and biologics seeking Breakthrough therapy or Priority Medicines designation, according to a new analysis.The findings highlight the need for agencies and sponsors to take advantage of collaborative opportunities, including the Parallel Scientific Advice program, to support global drug development that addresses unmet medical needs, wrote Zahra Hanaizi, of the EMA, along with colleagues at EMA and FDA, wrote in Therapeutic Innovation & Regulatory Science.

FDA’s expedited programs play increasing role in bringing novel drugs to market

Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan products using expedited programs alone in combination to achieve FDA approval more frequently over the last 13 years, according to recent research published in JAMA Network Open.

FDA updates guidance on expanded access for investigational drugs under IND

The US Food and Drug Administration (FDA) has updated its guidance for industry on expanded access to investigational drugs under an investigational new drug (IND) application. The guidance now includes new frequently asked questions about how expanded access should be implemented given new regulatory access and statutory requirements through the 21st Century Cures Act (Cures Act) and FDA Reauthorization Act of 2017 (FDARA).

FDA finalizes umbrella trial guidance for cell and gene therapies

The US Food and Drug Administration (FDA) laid out its recommendations for sponsors to study multiple versions of a cellular or gene therapy in a clinical trial for a single disease. The agency said its final guidance should help sponsors conduct umbrella trials of similar products for the same disease more efficiently to bring cell and gene therapies to market sooner.

FDA Finalizes Guidance on Cross-Labeling of Combination Oncology Drugs

Sponsors should be prepared to discuss proposed labeling for combination oncology drug regimens with the FDA in pre-application meetings, the agency said in a final guidance released yesterday.

AdComm Approves of FDA Plans to Further Develop and Expand KASA Program

An FDA advisory committee voted 13-0 yesterday in favor of the agency’s long-term strategy for its Knowledge-Aided Assessment and Structured Application (KASA) program, including expanding it from just generic drugs to new drugs and biologics assessments over the next five years.

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, 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.

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.

Accelerated Approval Changes Likely in 2023

Included in then stripped out of user fee legislation in September were requirements that the FDA and drug manufacturers agree on post-approval study conditions prior to a drug’s accelerated approval (AA) and require more regular study progress updates from manufacturers. The proposals also sought to permit the FDA to require studies to be underway at the time the drug is approved, or prior to that time, and to allow use of real-world evidence to support the studies.

FDA looks to modeling and simulation tools to streamline product reviews

The US Food and Drug Administration (FDA) recently published a report on how it uses modeling and simulation (M&S), highlighting the untapped opportunities to improve efficiency and predictability at the agency. Some of the key opportunities identified in the report are the need to develop guidelines for using such tools in the premarket setting and to harmonize how they are used among its product centers, international regulators and industry. Modeling and simulation are computational tools that can, as the name implies, be used to model and simulate how products and patients will perform.

ICH touts adoption of continuous manufacturing, safety reporting guidelines

The International Council for Harmonisation (ICH) announced that “excellent progress” has been made over the past year in advancing guidelines in the areas of pharmaceutical quality, safety and efficacy, including the adoption of the widely awaited guideline on continuous manufacturing (CM). These achievements were announced on 22 November following its meeting held in Inchon, South Korea. The meeting was held in parallel with meetings of ICH’s ten working groups and was preceded by an ICH Management Committee meeting. ICH said that “significant milestones” were reached and highlighted the adoption of the Q13 guideline on continuous manufacturing.

Industry asks FDA to align quantitative labeling guidance with other regulators

Pharmaceutical manufacturers said the US Food and Drug Administration (FDA) draft guidance specifying quantitative labeling recommendations for sodium, potassium and phosphorus in human over-the-counter (OTC) and prescription drugs conflicts with other existing guidelines and advice from other regulators. The comments were made in response to the agency’s call for feedback on the draft guidance, released in September 2022, which recommends quantitative labeling of sodium, potassium and phosphates. In the draft guidance, FDA wrote that quantifying these constituents would help health care providers manage their patients’ total daily intake when treating conditions such as heart failure, hypertension or chronic kidney disease.

Pakistan’s DRAP guidelines on preparing Summary of Product Characteristics

This document is applicable to the firms who intend to apply for registration / market authorization of human drug products. The guideline is intended to provide supportive information for preparation of Summary of Product Characteristics (SmPC) for registration / market authorization of pharmaceutical and biological products of all types including New drug products, Generic drug products and Biosimilars. This guideline provides advice on the principles of presenting information in the SmPC.

DRAP’s Call to Healthcare Professionals and Patients to Report Suspected Adverse Reactions of drugs and vaccines

The seventh annual Social Media Campaign #MedSafetyWeek was launched on the 7th of November, 2022 by the National Pharmacovigilance Centre, DRAP, which was observed until 13th November 2022, to encourage everyone to report suspected side effects of medicines. The International campaign was led by the Uppsala Monitoring Centre (UMC), the World Health Organisation (WHO) Collaborating Centre for International Drug Monitoring. This year’s global campaign involved medicines regulators from 81 countries and focused on the key role of every healthcare professional, patient, and caregivers who reports a suspected side effect and contributes to using medicines safely. This campaign was supported by the members of the International Coalition of Medicines Regulatory Authorities (ICMRA).

DRAP guidelines on Post Registration Variations of Pharmaceutical and Biological Drug Products

DRAP has finalized its guidelines on procedure and data requirement for post registration variation of pharmaceutical and biological drug products. This document will assist manufacturers and importers to incorporate variations in their product to account administrative changes, technical and scientific progress, or to improve or introduce additional safeguards. These Guidelines will assist both Regulators and Industry on the regulation of variation / changes to the original registrations / Market Authorization of products in terms of procedures and criteria for the appropriate categorization, reporting of changes and subsequent approval as required.

MSF accuses UK of ‘seeking to gut India’s patent and drug regulatory laws’

Médecins Sans Frontières (MSF) has accused the UK of trying to remove safeguards from India’s patent and drug regulatory laws that make the Asian country “a manufacturing powerhouse.” MSF made the statement after reviewing a leaked copy of a section of a draft free trade agreement (FTA).The leaked intellectual property chapter of the proposed FTA discusses topics including patents, stating that each country should provide pharma companies with “an adequate and effective mechanism to compensate the patent owner for the reduction in the effective patent term resulting” from the marketing authorization process. The compensation could either take the form of “a period of additional sui generis protection conferring the rights conferred by the patent” or “an extension of the patent term.” Aspects of the FTA caught the attention of MSF.“

Draft policy for approval of new drugs

CDSCO published draft policy for approval of new drugs. The content of New Drug Application (NDA) should be designed by the sponsor to answer general questions. There should be a system that before an NDA is submitted to the CDSCO, the applicant should discuss with CDSCO wherein the applicant may present summary of the clinical, CMC, Pre-clinical, Clinical and any other information the applicant considers relevant. Such discussion to help the reviewers becomes acquainted with the information to be included in the NDA. In case the sponsor intends to seek exemption of local clinical trial, clear request for the same should be made in the NDA along with rationale and justification and the relevant regulatory provision, under which the exemption is sought.

How adverse event reporting can enhance the safety of medicines

HSA published how adverse events reporting will enhance safety of medicines. This includeswhat is an adverse event, why medicines cause adverse events, why are some adverse events not detected before medicines are approved, what happens after an adverse event is reported to a doctor, and where adverse events are tracked. International collection of adverse event reports facilitatesbetter safety signal detection. According to HSA, adverse event reporting helps to make medicines safer.