July 19, 2023 BioPharma - Regulatory


FDA Issues Development Program Guidances to Assist Drug, Device Sponsors

The FDA published multiple guidances on Friday to help sponsors conduct drug-drug interaction studies for therapeutic proteins, develop drugs for treating bladder pain syndrome, nonclinical evaluation of drug immunotoxic potential and request feedback from agency officials on device submissions under the Q-Submission program.

FDA Adds to Migraine Drug Advice With Guidance Covering Preventive Treatments

Expanding on the clinical development of migraine drugs, the FDA has published a new draft guidance on development of drugs to prevent migraine to complement its current guidance on developing drugs to treat migraine.

Adverse Events Show Slight Rise in FDA Surveillance & Epidemiology Annual Report

CDER’s Office of Surveillance and Epidemiology (OSE) 2022 Annual Report showed the total number of adverse event (AE) reports rose slightly from 2.23 million in 2021 to 2.34 million, capturing patient adverse reactions along with medication error reports and product quality complaints.

Industry Shares Early Take on FDA’s Draft Decentralized Trial Guidance

The FDA’s long-awaited draft guidance on decentralized trials (DCT) is finally out and industry experts say that while the guidance has done many things right, recommendations on how sponsors monitor remote locations, such as in patients’ homes, may draw industry pushback.

FDA Proposes Rule to Replace Medication Guides With Single-Page Info Sheets

The FDA has proposed a rule to require sponsors of all new and already-approved outpatient prescription drugs and blood products to create a single-page Prescription Medication Information (PMI) sheet explaining how to use the drug, its benefits and its potential risks in plain, easy-to-understand language.

FDA Advises on Using Generally Accepted Scientific Knowledge in Applications

The FDA has spelled out when drugmakers may use generally accepted scientific knowledge (GASK) to support a drug or biologic application, in a new draft guidance.

ICH Advances Draft Guideline on Good Clinical Practice

The International Council on Harmonisation (ICH) has released a draft guideline on good clinical practice (GCP), designed to facilitate acceptance of clinical trial data by ICH member countries and regions.

Republicans Renew Call for ‘Reciprocity’ in FDA’s Approval Process

Republican lawmakers are renewing their push to speed FDA approvals by allowing the agency to automatically approve drugs and devices that have been approved and sold in other developed and trustworthy countries.

New FDA Product-Specific Draft Guidances Available for Generic Drug Development

The FDA has released 25 new product specific guidances (PSG) and 21 newly-revised PSGs that the agency provides to assist generic pharmaceutical manufacturers to develop drugs and generate the evidence needed to support ANDA approvals. These PSGs describe the agency’s current thinking and expectations on how to develop generics that are therapeutically equivalent to the reference listed drug. Issuing these PSGs is among the commitments included in GDUFA III, which the agency will prioritize based on public health priorities, drug availability and accessibility, public requests for guidance, stakeholder interest in ANDA submission.

Two New Draft Guidances Clarify Requirements for Pediatric Drug Development

Two draft guidances released by the FDA on Wednesday aim to reduce lag time between approval of a drug for adult use and its subsequent pediatric approval by clarifying requirements and processes for pediatric drug development.

FDA Requires Updates to ADHD Medication Labeling

Manufacturers of amphetamine and methylphenidate products, a class of stimulant medications used to treat ADHD and other disorders, must update their labeling and prescribing information to “clearly inform” patients, caregivers and healthcare professionals risks associated with these medications. Prescription stimulants can be important options for treating ADHD, binge-eating disorder, and uncontrollable episodes of deep sleep such as narcolepsy, however, even when prescribed to treat a specific condition, their use can lead to misuse or abuse.

FDA Seeks Feedback on AI and Machine Learning in Drug Development

The FDA is seeking feedback on a discussion paper focused on using AI and machine learning (ML) in drug development as well as in the development of medical devices intended to be used with drugs.

MDSAP QMS Implementation Plan Highlights Ongoing Assessments and Improvements

A new document from the Medical Device Single-Audit Program (MDSAP) outlines the program’s plan for implementing its Quality Management System (QMS) guidance on how to design, strengthen and develop quality management processes, products, outcomes and services.

FDA Final Guidance Details PDUFA VII Fee Program, Assessment Changes

Changes in the user fee program as a result of the Prescription Drug User Fee Amendments of 2022 (PDUFA VII) are detailed in a new FDA final guidance issued on Friday.

FDA Publishes MAPPs Update on Bioequivalence Studies With Clinical Endpoints

To reflect the more current organizational structure and processes in its Office of Generic Drugs (OGD), the FDA has published a manual of policies and procedures (MAPPs) update focused on bioequivalence (BE) studies with clinical endpoints.

FDA Adopts Revised ICH Guideline on Quality Risk Management

The FDA has adopted the International Council for Harmonization’s (ICH) revised guideline for quality risk management, releasing it in the form of a final agency guidance that advises pharma companies on risk management methodology, risk-based decision-making and managing subjectivity.

Guidance Explains How Drug and Device Sponsors Should Conduct DCTs

New digital technologies that enable clinical trials to take place in locations other than traditional trial sites are the subject of a long-awaited FDA draft guidance on conducting decentralized trials (DCT).


EU to Run Pilot to Test Real-Time Generated Human Medicine Product Information

The European Medicines Agency (EMA), along with the regulatory authorities of three member nations, is starting a one-year pilot to test the use of electronic product information (ePI) for human medicines in the EU.

EMA Publishes 10-Point Guideline on Preventing Drug Shortages

Marketing authorization holders, wholesalers, distributors and manufacturers should have a shortage prevention plan specific to their role and strengthen the reliability and resilience of their supply chains to help prevent a drug shortage, according to a new guidance from the European Medicines Agency.

EMA Seeks Public Comment on New Trial Data Transparency Rules

The European Medicines Agency (EMA) is seeking public comment on its transparency rules and protection of personal and commercially confidential data submitted to its clinical trials database.

MHRA outlines plans to recognize drug approvals from 7 global regulators

From the first quarter of 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) will implement an international recognition framework for medicines designed to “make the most of the expertise and decision-making of trusted regulatory partners to streamline assessments of specific products” thereby saving companies money and accelerating access, according to a 26 May statement from the regulator.

EMA won’t delay drug approval of combo product if diagnostic part doesn’t have CE mark

European regulators will not prevent approval of a drug if the device part of the combination product is delayed in getting certification from a notified body, an European Medicines Agency (EMA) official assured delegates at RAPS Euro Convergence. During a town hall meeting on 12 May with European regulators and notified body representatives, Marina Belonogova, associate director for diagnostics and digital health at Janssen Pharmaceutical, asked that if companies are putting themselves at risk if their drug and device components are not reviewed in parallel when trying to gain market authorization in the EU.



India starts mandatory tests of exported cough syrups after child deaths

India will require manufacturers of cough syrups to acquire a Certificate of Analysis (CoA) from a designated laboratory before they can export their products, starting 1 June. The new requirement follows the deaths of children who consumed cough syrups contaminated with ethylene glycol (EG) and diethylene glycol (DEG). The World Health Organization (WHO) linked some deaths to products manufactured in India. Until now, India has had a free export policy on cough syrups, meaning companies can ship products overseas without submitting paperwork to show they meet requirements that restrict the content of EG and DEG.


Applications for Registration of Multiple Strength and Volume Drugs (Pharmaceutical) on Form-5F

Drug Regulatory Authority of Pakistan, on the recommendations of the Registration Board has issued guidance for submitting applications for registration of pharmaceutical product with multiple strengths and different fill volumes on form -5F.

Application on Form-5F (CTD) for Extension in the Contract Manufacturing Permission of Drugs

Drug Regulatory Authority of Pakistan on the recommendation of the Registration Board has revised the data requirement for submitting applications for extension in the contract manufacturing permission of the drugs for those product where CTD dossiers has already been submitted and approved by the Registration Board.

Stakeholders Comments are invited on Draft Guidelines for Post-Registration Variation of Drugs

DRAP has rolled out a draft for the second edition of its guidelines on procedure and data requirement for post registration variation of drugs. These Guidelines are intended to 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. This guideline is intended to provide information for submission of post-registration variation application by the registrations / marketing authorization holders of drug products. It includes categories of variations and the required documentation & procedures for submission of an application for a particular variation.


Updated Guidelines on the Application for License to Operate of Health Product Establishments with the Food and Drug Administration

The Food and Drug Administration (FDA) is mandated to issue standards and appropriate marketing authorizations (MAs) to all its covered establishments, facilities, and health products. Through this endeavor, the FDA streamlined its processes through the establishment of various online application platforms for the issuance of MAs including License to Operate (LTO) for Manufacturers, Distributors, Traders, Drug Outlets, Retailers, Clinical Research Organizations, and other health establishments as determined by the FDA. In the interest of service and to seek the inputs of stakeholders that will be affected by the above-mentioned proposed policy, the FDA is respectfully inviting one (1) representative of each company/ organization from the health industry to attend the Public Hearing to be scheduled on the following dates at the FDA Conference Hall, Civic Drive, Filinvest, Alabang, Muntinlupa City.


Formulation Approval Applications for New Molecular Entities (NME)

All the local Manufacturers are hereby informed that if the molecule is a NME, such application should be submitted to NME Part 1 Pathway before applying for formulation approvals. After getting MEC approval for particular NME, those approvals should be attached to the formulation approval applications.


Guidance on therapeutic product registration in Singapore

This guidance document describes the procedures and requirements for submitting an application to register a therapeutic product, or to make a variation application to a registered therapeutic product. A therapeutic product registered under the HPA is specific to the product with respect to its: proprietary or brand name; pharmaceutical formulation; pharmaceutical dosage form (i.e. physical presentation) and strength; and indication(s) and dosing regimen.

HSA updates ICH CTD, ACTD checklists, submission requirements specific for MIV applications

Health Sciences Authority updates Appendix 2A – Application checklist for NDA and GDA (ICH CTD), Appendix 2B – Application checklist for MAV (ICH CTD), Appendix 3A – Application checklist for NDA and GDA (ACTD), Appendix 3B – Application checklist for MAV (ACTD), Appendix 12 – MIV self-guided tool for post-approval Variation Selection.

Guideline on prism submission

HSA updates appendix 17, Guideline on prism submission. This appendix primarily describes the processes for: Submitting a new product application, Submitting a variation product application, Responding to Input Request (IR) from HAS, Withdrawing a pending application.