USA and EUROPE Looking Ahead to 2020

USA – Food and Drug Administration (FDA)

The Center for Drug Evaluation and Research (CDER) continues its efforts to modernize the New Drugs Regulatory Program to better support patient needs and to strengthen public health protection. As part of this modernization initiative, CDER has issued new guidance documents and plans to release several additional documents throughout 2020.

Recently Published Guidance Documents (2020)

• Assessing User Fees under the Biosimilar User Fee Amendments of 2017 – Guidance for Industry 
• Hematologic Malignancies: Regulatory Considerations for the Use of Minimal Residual Disease in Drug and Biological Product Development 
• Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products and Biosimilars – Questions and Answers 
• Nonclinical Safety Evaluation of the Immunotoxin Potential of Drugs and Biologics – Guidance for Industry 
• Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications Using eCTD 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 Documents (Planned for 2020)

CDER intends to publish new and updated draft guidance across several categories, including clinical development, antimicrobial studies, clinical pharmacology, drug safety, electronic submissions, and labeling.

Examples 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) 
• Submitting Annual Status Reports and Other Submissions for Post‑marketing Requirements and Commitments (Forms FDA 3988 and 3989) 
• Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies 

Electronic Submissions

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

Labeling

• Dose Banding: Labeling Considerations 
• Geriatric Information in Prescription Drug and Biologic Product Labeling – Revised Guidance 
• Pregnancy, Lactation, and Reproductive Potential: Updated Labeling Requirements – Revised Draft 
• Quantification of Sodium, Potassium, and Phosphate in OTC and Prescription Drug Labeling 
• Regulatory Considerations for Software Output Used in Prescription Drug Use 

EUROPE – European Medicines Agency (EMA)

The European regulatory network for medicines consists of national regulators from all EEA member states, the EMA, and the European Commission. Its primary mission is to promote and safeguard public health through effective medicine regulation.

New Regulatory and Procedural Guidance (2020)

• Checklist for sponsors applying for orphan medicinal product designation transfer 
• Product Management Services (PMS): Implementation of ISO IDMP standards in Europe – Regulatory and Procedural Guidance (Chapters 1, 2, 6, and 7) 
• EMA pre‑authorization procedural advice for centralized procedure applicants (clean version and tracked‑changes version) 
• Guidance on labelling‑exemption requests under Article 63 of Directive 2001/83/EC 
• IRIS registration guidance 
• Electronic product information (ePI) for human medicines – Key principles 
• Procedural advice for orphan medicinal product designation 
• EMA recommendations on procedural and dossier requirements for consultations involving ancillary medicinal substances or human blood derivatives used in medical devices – Revision 1 

Eudora Vigilance Update

EMA has confirmed that from **30 June 2022**, reporting of side effects to EudraVigilance must follow ISO‑based international data standards:

• ISO 27953‑2:2011 – Individual Case Safety Report (ICSR) standard, aligned with ICH E2B(R3) 
• ISO/FDIS 11239:2012 – Standardized terminology for pharmaceutical dose forms and routes of administration, aligned with EMA’s Referential Management Service (RMS) 

These updates support improved data harmonization and enhanced pharmacovigilance across the EU.