Blogs

USA – Food and Drug Administration (FDA)

The Center for Drug Evaluation and Research (CDER) continues its initiation to modernize the New Drugs Regulatory Program to better serve patients and to protect and promote health. In its initiative to modernize the regulatory program, CDER has published new guidance documents and planning to publish few more in the year 2020.

Some of the newly added guidance documents in 2020:

• Assessing User Fees under the Biosimilar User Fee Amendments of 2017 Guidance for Industry. 
• Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment Guidance for Industry
• Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry
• Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics Guidance for Industry 
• Providing Regulatory Submissions in Electronic Format–Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications Revision 7
• Safety Testing of Drug Metabolites Guidance for Industry
• Providing Regulatory Submissions in Alternate Electronic Format
• ICH-Quality – Q3D(R1) Elemental Impurities Guidance for Industry

Upcoming Guidance’s: 

CDER plans to publish new and revised draft guidance’s during 2020 in Clinical/Medical, Clinical/Antimicrobial, Clinical Pharmacology, Drug Safety, Electronic Submissions and labeling categories. Some of the guidance’s include

Drug Safety:

• Best Practices in Developing Proprietary Names for Human Non-Prescription Drug Products 
• Definitions of Suspect Product Revised Guidance under the Drug Supply Chain Security Act 
• Investigator Responsibilities − Safety Reporting for Investigational Drugs and Devices 
• Post-marketing Safety Reporting for Human Drugs and Biological Products Including Vaccines, Revised Draft 
• Post-marketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act 
• Submitting Annual Status Report Information and Other Submissions for Post-marketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 
• Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies

Electronic Submissions:

• Establishment Registration and Drug Listing 
• Providing Regulatory Submissions in Alternate Electronic Format 
• Providing Regulatory Submissions in Electronic Format – Bio-analytical Methods Data Standards

Labeling:

• Dose Banding: Considerations for Labeling 
• Geriatric Information in Human Prescription Drug and Biological Product Labeling; Revised Guidance 
• Pregnancy, Lactation and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products; Revised Draft 
• Quantification of Sodium, Potassium, and Phosphate in Human Over-the-Counter and Prescription Drug Labeling 
• Regulatory Considerations for Prescription Drug-Use-Related Software Output

EUROPE – European Medicines Agency (EMA)

The European regulatory system for medicines is a network of all the national medicines regulators from EEA member states, the European Medicines Agency (EMA) and the European Commission. The ultimate role of this network is to promote and protect the health of those it serves through medicines regulation. 

Some of the newly added Regulatory and Procedural Guidances, 2020:

• Checklist for sponsors applying for the transfer of orphan medicinal product designation. 
• Products Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe – Regulatory and procedural guidance for Introduction – EU implementation Guide, chapter 1, 2, 6 and 7. 
• European Medicines Agency pre-authorisation procedural advice for users of the centralized procedure. 
• European Medicines Agency pre-authorisation procedural advice for users of the centralized procedure: document with tracked changes.
• Labelling-exemption requests under Article 63 of Directive 2001/83/EC examined by the Quality Review of Documents group.
• IRIS guide to registration
• Electronic product information for human medicines in the European Union – key principles
• Procedural advice for orphan medicinal product designation: Guidance for sponsors
• EMA recommendation on the procedural aspects and dossier requirements for the consultation of the EMA by a notified body on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device – Revision 1

EudraVigilance: 

EMA specified that it is mandatory to report side effects to EudraVigilance using a data format based on international standards set by the International Organization for Standardization (ISO) effective from 30 June 2022. The two ISO standards that will apply include:  

1. Individual Case Safety Report (ICSR) standard (ISO 27953-2:2011) and the modalities on how to implement this standard, as defined in the ICH E2B(R3) guideline;
2. Terminology on pharmaceutical dose forms and routes of administration (ISO/FDIS 11239:2012), in line with EMA’s Referential Management Service (RMS).