Pharmaceutical Regulatory Updates

We know how important regulatory compliance is to you, so here are the latest updates.

Please note that our regulatory updates page is designed to give a brief overview of some of the most recent regulatory updates for the Pharmaceutical industry. We recommend reading the complete articles from the publication source and, if necessary, contacting the regulatory body for clarification or comments. In publishing these regulatory update briefs Lucideon Ltd in no way recommends that readers take any actions and will not be responsible for consequences should actions be taken due to the content of these updates.


Self-Identification of Generic Drug Facilities, Sites, and Organizations

This guidance offers advice on how individuals, facilities and sites should comply with self-identification requirements contained in GDUFA for human generic drug facilities, sites and organizations. The self-identification...(see full article).


FDA Publishes Industry Guidance on Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

This draft guidance has been published to offer advice for both drug sponsors developing new antimicrobial drugs and device manufacturers developing antimicrobial susceptibility test (AST) devices and who wish to coordinate the release of...(see full article).


FDA Publishes Industry Guidance on ‘Microbiological Data for Systemic Antibacterial Drugs – Development, Analysis and Presentation’

The FDA has published guidance to assist sponsors in the development, analysis and presentation of microbiology data during antibacterial drug development. Microbiological data provides important information for the development of investigational new...(see full article).


The FDA Releases Guidance on the Regulatory Classification of Pharmaceutical Co-Crystals

The FDA have published guidance ‘Regulatory Classification of Pharmaceutical Co-Crystals’ to provide information on the appropriate regulatory classifications of pharmaceutical co-crystal solid-state forms. The guidance is aimed at applicants...(see full article).


The FDA releases industry guidance on ‘Insanitary Conditions at Compounding Facilities’

The FDA has published guidance on ‘Insanitary Conditions at Compounding Facilities’. It concerns adulterated drug products which could include products prepared, packaged or held under insanitary conditions that could have become contaminated...(see full article).


Proposals to Revise Guidance on First-in-Human Clinical Trials

The European Medicines Agency (EMA) has issued new guidance on first-in-human clinical trials which has been released with an invite for comments to be made by the 30th September 2016.  The guidance proposes strategies for identifying...(see full article).


FDA Releases Guidance for Compounded Drug Products under Section 503B

This FDA draft guidance, ‘Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act’, offers recommendations to outsourcing facilities performing...(see full article).


FDA Releases Guidance for Compounded Drug Products under Section 503A

This FDA draft guidance offers recommendations to pharmaceutical prescribers and compounders on the best practices and correct procedures for compounding drugs for patients as an alternative to commercially available drug products....(see full article).


The FDA Releases Guidance on General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products

This guidance has been issued by the FDA mainly to assist a potential applicant who plans to develop, and submit an abbreviated new drug application (ANDA) to seek approval for, a generic version of a solid oral opioid drug product that has....(see full article).


The EMA Launches PRIME for Faster Drug Development

The European Medicines Agency (EMA) has launched its new PRIME (PRIority MEdicines) scheme which help to support the production of regulatory data required for medical applications. The scheme is targeted at medicines that offer a treatment to a...(see full article).


FDA Draft Guidance for Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development

The FDA has published guidance on minimizing the risks introduced by user-related misuse, as this poses a significant barrier to successful administration and dosage of drugs. For combination products this means taking into consideration potential human factors...(see full article).


EMA Releases New International to Improve Medicine Safety

The European Medicines Agency (EMA) has produced guidance to complement its new standard, ISO ICSR. ISO ICSR (which should come into effect on the 1st July 2016) is aimed at helping safety monitoring of medicines within the EU by regulating the format...(see full article).


Modernizing Drug Technologies for a Safer and Reliable Pharmaceutical Supply Chain

The FDA has recently issued new guidance, alongside its new Emerging Technology Team (ETT), to help the pharmaceutical industry better understand, develop and implement new manufacturing technolog...(see full article).


HPRA Guide to Biosimilars

The Health Products Regulatory Authority (HPRA) has issued guidance on the regulatory assessment process for the authorization of biosimilar drugs as directed in medical legislation. The guidance provides advice including the difference between biosimi...(see full article).


EMA Health Based Exposure Limits Examined by Industry Workgroup – the Results

An industry workgroup comprised of toxicologists and manufacturing equipment cleaning experts was formed to examine the EMA guidance on shared facilities and in particular the provision for alternative approaches and how to implement them. The resulting paper ...(see full article).


FDA Releases ICH Q3D Final Guidance on Elemental Impurities

New guidance has been issued which identifies the permitted daily exposures of 24 elements found in pharmaceutical products. The assessment also covers the likelihood of any one of the 24 elements being found in a pharmaceutical product...(see full article).


The World Health Organisation Publishes Supplementary Guidelines for Good Manufacturing Practices

The World Health Organisation (WHO) has published supplementary guidelines for the correct use of heating, ventilation and air-conditioning (HVAC) systems in manufacturing environments of non-sterile pharmaceutical dosage forms to ...(see full article).


FDA Publishes Guidance on Patient Friendly Tablet Shapes and Sizes

The FDA guidance document highlights the importance of the size and shape of a drug for a patient, for drugs to be taken via swallowing in tablet or pill form. The FDA is recommending that manufacturers of generics take this into consideration as part...(see full article).


FDA Guidance for Abuse-Deterrent Opioids

The new guidance outlines properties which are considered to provide meaningful abuse deterrence for opioid products for product manufacturers to consider when developing new technologies. ...(see full article).


EMA Policy on Publication of Clinical Data for Medicinal Products for Human Use

The European Medicines Agency (EMA) has released a new publication for the release of clinical data for human medicinal products. The publication is designed to make the process of approval...(see full article).