During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month reported issues have come from China, the EU, Swiss, USA & PIC/s regulatory authorities
The topics covered in this edition of the “Update” include
Europe
Commission Directive (EU) 2017/1572
Commission Delegated Regulation (EU) No 2017/1
Memorandum of Understanding on use of CEPs in Brazil
EU/US mutual recognition of inspections of medicines manufacturers enters operational phase.
New action plan to foster development of advanced therapies
EMA publishes comments on Member States’ hosting bids
Countdown to launch of new EudraVigilance System
Better labelling of excipients for safe use of medicines
EMA Management Board: highlights of October 2017 meeting
International regulators inspecting in the UK
Potential supply issues
USA
ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin
Formal meetings between FDA and ANDA applicants of complex products under GDUFA
ANDA Submissions – Prior Approval Supplements Under GDUFA
ANDA submissions –refuse-to-receive standards: Q&A
ANDA Submissions — amendments to abbreviated new drug applications under GDUFA
Post-complete response letter meetings between FDA and ANDA applicants.
Determining whether to submit an ANDA or a 505(b)(2) application.
International
China
China to accept overseas trial data in bid to speed up drug approvals
PIC/s
Pakistan applies for PIC/S pre-accession
PIC/S meeting / training – Sept 2017
Switzerland
Cross border inspections
Products
New review of hydroxyethyl-starch containing medicines
FDA lab findings again link Rugby Diocto oral liquid docusate sodium to B. cepacia infections
Print Page
Email to a Friend