Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – March 2024

USA

Three FDA Final Guidance’s on Electronic Submission of Safety Reports

Three FDA final guidance’s address electronic submissions for reporting adverse reactions — one for investigational new drug application (IND) safety reports, one for transmitting electronic individual case safety reports (ICSR), another for ICSR attachments to the FDA Adverse Event Reporting System (FAERS) database and a third for expedited ICSRs from certain IND-exempt studies.

OTC Monograph Facility Fee Rates Increase by 23 Percent

The FDA announced a 23 percent increase in the OTC Monograph Drug User Fee Program (OMUFA) facility fee rates for FY 2024.

Procedures for BA, BE Testing Samples Handling, Retention

The FDA’s guidance on the quantity of bioavailability (BA) and bioequivalence (BE) testing samples to be retained by NDA applicants and contract research organizations (CRO) contains both draft and final language focusing on both the test article and reference standard.

Using RWD in Non-interventional Studies

In a nod to the increasing potential of demonstrating drug/biologic safety and/or effectiveness through non-interventional studies, the FDA has published long-awaited draft guidance on designing and analyzing such studies with real-world data (RWD) in mind.

 “Demonstrably Difficult” Compounded Drugs/Categories

An FDA proposed rule will establish criteria the agency will use to create two lists — drug products and categories of drug products — that present demonstrable difficulties for compounding (DDC Lists) and identify three categories of drug products on both DDC Lists.

Controlled Correspondence Guidance for Generic Drugmakers

The FDA has issued a final guidance on the process generic drug manufacturers can use to correspond with the agency on generic drug development, the agency’s process for responding and for manufacturers to clarify ambiguities in what the FDA refers to as “controlled correspondence.”

Advanced Manufacturing Guidance Needs Detail on Benefits

The FDA’s draft guidance on its Advanced Manufacturing Technologies (AMT) program is a great start for encouraging industry to develop these systems but it needs a lot more detail before businesses will wholeheartedly embrace it, according to stakeholder comments.

Definitions and Standards for Post approval Safety Data

The FDA has adopted an updated guidance from the International Council on Harmonization (ICH) that provides clarification on how to factor in new and increasingly used data sources, such as social media or patient support programs, when reporting individual case safety reports post approval.

Exporting Investigational New Drugs

FDA updated Exporting requirements of Investigational New Drugs.  The drug is required to be exported in accordance with the laws of the foreign country and comply with the basic export requirements in section 802(f) of the FD&C Act. The exporter, under section 802(g) of the FD&C Act, must maintain records of all drugs exported and the countries to which they were exported.

FDA Endorses Pair of ICH Final Guidelines on Analytical Procedures

The FDA has endorsed International Council for Harmonisation (ICH) recommendations, publishing this week final guidances covering analytical procedure development and validation of such procedures, while the ICH itself has announced revisions to a guidance on residual solvents for analytical methods.

FDA Modernizes Informed Consent Guidance, Aligning With Common Rule Changes

The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing of essential clinical trial information in ways that patients can understand.

Controlled Correspondence Related to Generic Drug Development

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Controlled Correspondence Related to Generic Drug Development.”  This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency’s process for providing communications related to such correspondence.  This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA’s controlled correspondence response and the Agency’s process for responding to those requests. 

EUROPE

New Products’ Data Protection Shortened by 6 Months in Proposed EU Drug Legislation

The EU’s Environment, Public Health and Food Safety Committee (ENVI) has supported a legislative proposal that would grant up to 7.5 years of regulatory data privacy to pharmaceutical companies developing new drugs, effectively trimming six months of protection from the current eight years for some products.

Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation

This Guidance (version 3) reflects the agreement reached by the National Contact Points and supersedes the chapter 11 of the Q&A on the application of the CTR (version 6.4). From 31 January 2025 onwards only the Clinical Trials Regulation (EU) 536/2014 (CTR) and its Delegated Acts will apply, as laid down in Article 98 thereof.

Explanatory note on general fees payable to the European Medicines Agency

EMA updated explanatory note on general fees payable to the European Medicines Agency. Changes in this version are Increase in the level of fees other than administrative fees to adjust for an inflation rate of +3.4% and rounding off to the nearest EUR 100, Increase in the level of all administrative fees to adjust for an inflation rate of +3.4% and rounding off to the nearest EUR 10.

Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable)

EMA updated Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable). For the submission of the full set of annexes, [i.e. Annex I (SmPC), Annex II, Annex IIIA (labelling), Annex IIIB (package leaflet) and Annex A (if applicable)] in all EEA languages, the applicant/MAH confirms that applicant have prepared the files in accordance with the checklist.

Pharmacovigilance assessment information sharing

EMA updated template for Pharmacovigilance assessment information sharing. This template is intended for assessors to share specific product and/or pharmacovigilance system issues detected during an assessment of a marketing authorisation application or any other pharmacovigilance assessment in the product life cycle. Please provide as complete information as possible.

AUSTRALIA

Advertising services that involve therapeutic goods

Advertising services that involve therapeutic goods version 2 was published by TGA. To ensure that advertisement for a health service is not also considered an advertisement for therapeutic goods, it is best not to refer to any therapeutic goods used in the delivery of the service in the advertisement. Advertising services that unavoidably involve therapeutic goods generally need to comply with the legislative requirements for advertising therapeutic goods as well as any requirements governing the advertising of services.

Clinical Trial Notification (CTN) form User guide

TGA published Clinical Trial Notification (CTN) form User guide version 1.3. All clinical trials conducted in Australia must have a trial sponsor that is an Australian entity (an overseas company cannot be the sponsor of a trial in Australia). Sponsors of trials under the CTN or Clinical Trial Approval (CTA) schemes may include individuals, companies, institutions, or organizations.

CROATIA

Price list of the services of the agency for drugs and medical products

Halmed published Price list of the services of the agency for drugs and medical products  which are effective from march 9^th, 2024. The price list will apply to all services such as registration, renewal performed and invoiced by HALMED after the date of entry into force.

DENMARK

Reporting of side effects

A new standard for the reporting of side effects in the EU has come into force – the E2B(R3). In relation to this, DMA have developed a new, simplified and user-friendly side effect reporting solution that meets the new standard. For instance, DMA have gathered all previous e-forms in a one flexible solution that adapts based on the replies. Healthcare professionals, medicine users, carriers or relatives can report suspected adverse reactions (side effects) of medicines for human use on the e-form.

EGYPT

GUIDELINES ON Naming of Human Pharmaceutical Products

A draft guideline on naming of Pharmaceutical Products was released in Egypt. The fourth version of the naming guidelines replaces traditional letter-count method with 3 more advanced approach using phonetic and orthographic similarity score using the EDA 4 Naming Checker Tool. This update also incorporates the consideration of the 5 international non-proprietary names (INN) and U.S. Adopted Names (USAN) in 6 reviewing proposed trade names. The guidelines provide detailed procedures for 7 evaluating proposed trade names, ensuring that they are not confusingly similar to 8 existing names and that they are not likely to cause safety concerns or negative 9 connotations.

IRELAND

Renewal of Marketing Authorizations – Human Medicines

Renewal of Marketing Authorisations – Human Medicines guidance document version 7 is published by HPRA. An application for renewal of a marketing authorisation (MA), irrespective of whether the product is authorised nationally or through mutual recognition (MR), must be made using the EU application form for renewal of a marketing authorisation, available from the website of the EU Commission.

MALAYSIA

Guideline for application of clinical trial import licence (CTIL) and clinical trial exemption (CTX)

The guideline is intended to assist the applicant in making a CTIL/CTX application to the NPRA and reporting to the NPRA during and at the end of a clinical trial. This guideline is issued by the Director of Pharmaceutical Services (DPS) under regulation 29, Control of Drugs and Cosmetics Regulations (CDCR) 1984. This guideline is to be read in connection with the legal requirements of the CDCR 1984, Sale of Drugs Act 1952 and Poisons (Psychotropic Substances) Regulations 1989.

NEW ZEALAND

Guideline on the Regulation of Therapeutic Products in New Zealand

Medsafe updated Guideline on the Regulation of Therapeutic Products in New Zealand. The Pharmacovigilance Guideline provides information for sponsors about their pharmacovigilance obligations and responsibilities for their medicines that they supply and distribute in New Zealand. The Guideline also includes recommendations to sponsors that are not currently underpinned by medicines legislation and provides guidance on best practice of pharmacovigilance.

PAKISTAN

Guidelines on labeling and packing of pharmaceutical and biological drugs

DRA published Guidelines on labeling and packing of pharmaceutical and biological drugs. The purpose of this guideline is to provide guidance on how to ensure that the information as required under Drug Labeling & Packing Rules 1976 shall be provided on the label on primary and secondary packaging. This guideline is written to assist applicants and marketing authorization holders when drawing up the label for primary and secondary packaging.

Patient information leaflet (pil) guidelines

DRA published Patient information leaflet (pil) guidelines. This document applies to the firms who intend to apply for registration/market authorization and post-registration variation of pharmaceutical and biological drug products for human use.  The guideline is intended to provide supportive information for the preparation of a Patient Information Leaflet (PIL) 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 PIL.

SINGAPORE

Points to consider for Singapore labelling

HSA published points to consider for Singapore labelling. All product labelling must be in English. If non-English text is included in the labelling, applicants must provide an official statement declaring that the nonEnglish text is complete, accurate, unbiased and consistent with the English text. Information provided in the labels should be consistent with the information submitted in the application dossier.

SOUTH AFRICA

Guideline for professional information for human medicines (categories a and d)

SAPHRA published Guideline for professional information for human medicines (categories a and d). Amendment to include CHMP guideline on risk of medicinal product on human reproduction and lactation: from data to labelling. The intention of this guideline is to: Help applicants with the correct way of presenting the PI for evaluation; and Enhance consistency in the content of the PI.

Progress report form after use of an unregistered product

HSAPHRA published progress report form after use of an unregistered product. This form is of revision 3 and incudes details such as particulars of patient, unregistered product.