Regulatory questions, answered.
Questions asked in RegAffairs AI and answered from official sources, with every claim cited to the document it came from.
Is titanium dioxide (E171) permitted as a food additive in the EU, the UK, the US and Canada? Give the current status, legal basis and dates in each market, with citations.
The EU and the US/Canada now point in opposite directions. Titanium dioxide is banned as a food additive in the EU (including Northern Ireland).
Is cannabidiol (CBD) authorised as a novel food in the EU, and what is the status of CBD food products in Great Britain under the FSA public list? Cite the official sources.
No. Cannabidiol is not authorised as a novel food in the EU, and it is not yet authorised in Great Britain either.
What is the EU maximum level for aflatoxins in pistachios, and what RASFF notifications for aflatoxins in pistachios were reported in 2026, by origin country?
EU maximum levels: Under Annex I of Regulation (EU) 2023/915, as consolidated on 8 October 2025, the limits for pistachios depend on what happens to the nuts…
Has NICE issued a technology appraisal for tirzepatide (Mounjaro) in England, and what did it recommend? Is it reimbursed in Italy (AIFA) and South Korea (HIRA)? Cite each source.
England: Yes. NICE has published two technology appraisals for tirzepatide (Mounjaro, Eli Lilly).
Is apixaban (Eliquis) approved in Switzerland, Japan and Canada? Give the authorisation holder, approval date and product or registration numbers from Swissmedic, PMDA and Health Canada, with citations.
Yes. Apixaban is approved in all three countries, and the originator Eliquis is held by Bristol-Myers Squibb companies.
Is zinc pyrithione allowed in rinse-off cosmetic products in the EU and in Great Britain? Give the Annex entry and any restriction, with sources.
No. Zinc pyrithione cannot be used in rinse-off cosmetic products in either the EU or Great Britain.
Is DEHP (CAS 117-81-7) on the REACH Authorisation List (Annex XIV), and what latest application date and sunset date apply to its use in medical devices under the MDR and IVDR?
Yes. DEHP (EC 204-211-0, CAS 117-81-7) is entry 4 on the REACH Authorisation List (Annex XIV).
Medium-chain chlorinated paraffins (MCCP) are in a cable sheath we put in electronic products sold in the EU. Are MCCPs on the REACH Candidate List, restricted under REACH Annex XVII or the EU POPs Regulation, and what are our Article 33 and SCIP duties?
Short answer: Yes, MCCP is on the REACH Candidate List. It is not in REACH Annex XVII.
Which FDA warning letters were issued to drug manufacturers for CGMP violations in 2026? List company, date, facility country and the main cited violations (21 CFR 211), with links to the letters.
I found 29 FDA warning letters issued between January and September 2026 to drug manufacturers for CGMP violations under 21 CFR parts 210/211.
Is there a current shortage of amoxicillin in the US, EU, UK and Germany? Compare what FDA, EMA, MHRA and BfArM report, with dates.
Germany is the only one of the four with an open amoxicillin shortage: BfArM lists a single active report, for one product.
When did FDA first approve semaglutide, under which NDAs and brand names, and what indications were added later? Cite Drugs@FDA.
FDA first approved semaglutide on 5 December 2017, as Ozempic injection for type 2 diabetes under NDA 209637 (Novo Nordisk).
Is tirzepatide centrally authorised in the EU? Give the product names, marketing authorisation holder, authorisation date, approved indications and any EMA safety updates, citing the EPAR.
Yes. Tirzepatide is centrally authorised in the EU as one product, Mounjaro (EMEA/H/C/005620).
What patents and exclusivities are listed in the FDA Orange Book for apixaban (Eliquis), when do they expire, and which generic ANDAs are approved?
The FDA Orange Book lists two patents for Eliquis (apixaban) tablets: US 6,967,208, which expires Nov 21, 2026, and US 9,326,945, which expires Feb 24, 2031.
Can a CE-marked medical device still be placed on the Great Britain market, until when, and what does MHRA registration require?
Yes. A CE-marked device can still be placed on the Great Britain market, but only until fixed transitional end dates, and it must be registered with the MHRA…
Under IVDR 2017/746, how is a companion diagnostic classified, and what transition deadline applies to legacy Class D devices under Regulation (EU) 2024/1860?
A companion diagnostic is a Class C device under the IVDR. Regulation (EU) 2024/1860 lets legacy Class D devices stay on the market until 31 December 2027…
Which EUDAMED modules are mandatory to use as of 2026, from what date, and what legal act triggered it?
Answer: Four EUDAMED modules have been mandatory since 28 May 2026: Actor registration, UDI/Device registration, Notified Bodies & Certificates, and Market…
Under EU MDR 2017/745, what classification rule applies to standalone software intended to inform decisions for diagnosis, and what class results? Compare with the FDA approach.
Under the EU MDR, standalone software intended to provide information used to take diagnostic or therapeutic decisions falls under Rule 11 of Annex VIII.
What is FDA product code DQY, what device class and regulation number is it, and list a few recent 510(k) clearances under it with K numbers.
FDA product code DQY is "Catheter, Percutaneous". It is a Class II device under 21 CFR 870.1250 (percutaneous catheter), cleared through the 510(k) pathway by…
What are the GMP requirements for drugs in Canada? Cover Part C Division 2 of the Food and Drug Regulations (C.02.001 to C.02.030), Health Canada's GMP guide GUI-0001, GMP inspections and ratings, and how Canadian GMP compares with US FDA cGMP (21 CFR 210/211).
Canadian drug GMP is set out in Part C, Division 2 of the Food and Drug Regulations, and it is enforced through the drug establishment licence (DEL) required…
Quel est le statut réglementaire du glyphosate (CAS 1071-83-6) en France en 2026 ? Couvrir le renouvellement de l'approbation UE (règlement d'exécution (UE) 2023/2660), les produits autorisés par l'ANSES et leurs restrictions d'usage (retraits, limitations de 2020), l'interdiction pour les particuliers et les espaces publics (loi Labbé), l'importation de produits achetés en Espagne, les sanctions, le crédit d'impôt pour sortie du glyphosate, et où trouver les doses autorisées (E-Phy).
En 2026, le glyphosate est approuvé dans l'UE jusqu'au 15 décembre 2033 et autorisé en France.