The Ph. Eur. Suppl. 11.5 is now available containing the new Ph. Eur. Cannabis Flower monograph and the new Ph. Eur. monograph Cannabidiol (CBD). The Ph. Eur. CBD monograph now clearly defines: CBD is isolated from the Cannabis sativa L. plant.
Combination products (the combination of a medicinal product and a medical device) are increasingly "on the rise". However, the regulation governing these combination products is very complex. For the EU area, the EMA Q&A document Questions & Answers for applicants, marketing authorization holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) provides assistance in this regard. The document was revised at the end of 2023. What is new?
The results of a survey of 39 Notified Bodies were published by the EU Commission at the end of 2023. It concerns certifications and applications under the Medical Device/IVD Regulations (MDR/IVDR). What are the results?
With the implementation of the Medical Device Regulation (MDR), a "responsible person" according to Article 15 MDR also became mandatory. Minimum requirements for this "person responsible for regulatory compliance" are specified in this article. Further information can be found in the guideline "MDCG 2019-7", which has now been revised. What are the changes?
Following the previously confirmed falsifications of Ozempic® batches in the EU drug supply chain, the FDA now warned consumers not to use counterfeit Ozempic® found in the US drug supply chain.
In December 2023, the U.S. FDA issued a Warning Letter (WL) to the US American company "Inopak, Ltd." after having inspected its site in July and August 2023. According to U.S. FDA Warning Letter, the firm failed to maintain an ongoing stability program for their drug product.
The FDA issued the final guidance on cosmetic product facility registrations and product listings, as mandated by the MoCRA. Amongst others, the guidance contains information about a new electronic registration and listing submission portal: Cosmetics Direct which is now available.
The FDA announced the availability of SPL Xforms, a Structured Product Labeling (SPL) authoring tool for cosmetic product facility registration and cosmetic product listing. In addition, paper forms are now available.
Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 16: What are the consequences of the different service models (IaaS / PaaS / SaaS / XaaS) for supplier management and the related qualification / validation?
The ECA Analytical Quality Control Group (AQCG) has developed a new Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation. Version 1 of the new document is now available for download free of charge in the AQCG members' area.
On 29 November 2023, a new FDA Form 483 that goes back to an inspection in October at a company in India was published. The 23-page report lists a total of 10 observations. Beside others, laboratory equipment including HPLCs, GCs, and UV Spectrophotometers used in commercial release and stability analysis were observed not meeting the calibration specifications.
After the final texts of the ICH Guidelines Q2(R2) and Q14 were adopted at the ICH Assembly Meeting on 31 October and 01 November 2023, the documents are now available for download on the ICH website.
The current version of the EMA/CMDh nitrosamine Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products", dated October 2023, contains Annex 1 and three further appendices (Appendix 1-3). In December 2023, Appendix 1 was updated and now contains five additional substances.
Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 15: Special considerations for validation of SaaS; who is accountable?
The ECA Analytical Quality Control Group (AQCG) met in-person on 20 November 2023 in Düsseldorf/Neuss, Germany. During this Board Meeting, several decisions were made concerning both the composition of the Board and the work program for the coming months.
With regard to the "CEP 2.0", the EDQM has once again provided information on the "EMA SPOR/OMS ORG_IDs" and "LOC_IDs" ("unique identifiers for an organisation" / "unique identifiers for its locations") on its website.
The FDA issued the final guidance on verification systems under the DSCSA. The document covers "suspect drug systems" that trading partners must have in place to detect and respond to suspect drugs and ultimately notify the FDA if needed.
In a recent Warning Letter from the US FDA, the authority refutes a medicinal product manufacturer's argument that a failure rate of 0.011% does not trigger further action. How does the FDA argue here?
FDA's Center for Drug Evaluation and Research (CDER) announced that the center is soliciting public comments to understand the state of innovation in clinical trial design and conduct. The CDER is gathering information from internal and external stakeholders on the barriers and facilitators to incorporating innovative clinical trial approaches in drug development programs.
The EMA and the HMA published revised guidance documents relating to the CTIS transparency rules and the transition of clinical trials. Amongst others, the concept of consolidated protocols has been clarified by providing an example illustrating the transition of a CTD trial to the CTR with different protocol versions approved in the Member States Concerned.
In addition to the recently published FDA guideline on Quality Considerations for Clinical Research with Cannabis the FDA now published an article to assist researchers with developing cannabis-derived product (CCDP) clinical research programs.
The U.S. Food and Drug Administration (FDA) published the final guidance on Benefit-Risk Assessment. According to the agency, the intent of the guidance is to clarify how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions.
Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. The FDA has now published the data for the fiscal year 2023. As in previous years, we have again performed an evaluation with regard to deficiencies in the stability programme.
The validity of EU GMP and GDP certificates is to remain in place until 2024 or until the completion of the next on-site inspection, whichever comes first. Until then, supervision will be performed risk-based.
