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News & Press: Regulatory Updates

PHSS Nov 2017 Reg Update: Comm DRR (EU) No 2017/1; China accept trial data to speed up drug approval

08 November 2017   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update November 2017


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



  •  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



  • 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.




  • China to accept overseas trial data in bid to speed up drug approvals


  • Pakistan applies for PIC/S pre-accession
  •  PIC/S meeting / training – Sept 2017


  • Cross border inspections


  • New review of hydroxyethyl-starch containing medicines
  • FDA lab findings again link Rugby Diocto oral liquid docusate sodium to B. cepacia infections

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