Guideline Update February 13, 2018


Guideline Update Jan & Feb, 2018

All Guideline Updates Up To February 13 of 2018

It’s only February and already the European Medicines Agency (EMA), the U.S. FDA and other worldwide organizations such as the WHO, ICH and PIC/s have released a number of guidances. We’ve made a comprehensive list of these guidelines, their importance and possible changes as opposed to other versions.

PCS has a team dedicated to keeping you up to date with the regulatory changes worldwide to make your job easier. If you need any help or guidance implementing these guidances please contact PCS. Besides the regulatory guidance, we will include documents which we deem important to the industry. These documents may not carry any legislative weight.


European Medicines Agency (EMA)

The EMA has released seven relevant documents since January 1st, 2018. 

  • Draft Guideline on safety and efficacy follow-up and risk management of Advanced Therapy Medicinal Products (February 1st, 2018)
  • Commission Report on Member State penalties for the falsification of medicines (January 26th, 2018)
  • Updated procedural advice clarifies regulatory process for advanced therapy medicinal products (February 1st, 2018)
  • Q&A European Medicines Agency pre-authorisation procedural advice for users of the centralized procedure (February 6th, 2018)
  • Pharmacovigilance for advanced therapies (February 2018)
  • Q&A on bovine spongiform encephalopathies (BSE) and vaccines (February 1st, 2018)
  • Draft Guideline on quality aspects included in the product information for vaccines for human use (February 1st, 2018)

 Download Our Comprehensive Overview Including Download Links Here (Microsoft Word).

U.S. Food and Drug Administration (FDA)

The U.S. FDA has released ten relevant documents since January 1st, 2018. 

  • Two Warning Letters
  • Two FDA 483’s
  • Draft Guidance: Good ANDA Submission Practices (January 2018)
  • Draft Guidance: Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format (January 2018)
  • Final Guidance: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product under Section 503A of the Federal Food, Drug, and Cosmetic Act (January 2018)
  • Guidance Revision 2: Microbiology Data for Systemic Antibacterial Drugs —Development, Analysis, and Presentation (February 2018)
  • Guidance: This guidance sets forth FDA’s policy regarding the mixing, diluting, and repackaging of certain types of biological products that have been licensed under section 351 of the Public Health Service Act (PHS Act) when such activities are not within the scope of the product’s approved biologics license application (BLA) as described in the approved labeling for the product (January 2018)
  • Draft Guidance: Qualified Infectious Disease Product Designation Questions and Answers Guidance for Industry (January 2018)

 Download Our Comprehensive Overview Including Download Links Here (Microsoft Word).

World Health Organization (WHO)

The U.S. FDA has released one relevant document late December 2017


The proposal is to replace the text: WHO good manufacturing practices for sterile pharmaceutical products published as Annex 6, WHO Technical Report Series, No. 961, 2011, by the text of the newly revised “EU-PIC/S GMP Annex 1 on the Manufacture of Sterile Medicinal Products” which has reached Step 2 (public consultation).

The new draft EU GMP Annex 1 is made in cooperation with the EU, PIC/S, and WHO.

The new draft for the EU GMP Annex 1 will also be adopted by the WHO to replace the current TRS 961 Annex 6. It is an effort from the EU, PIC/S and the WHO to harmonize GMP.

 Download Our Comprehensive Overview Including Download Links Here (Microsoft Word).


Geneva, 20 December 2017: a revision of Annex 1 (Manufacture of Sterile Medicinal Products) of the PIC/S and EU GMP Guides has been prepared in co-operation with the European Medicines Agency (EMA), WHO and PIC/S in order to maintain global alignment of standards, achieving at the same time assurance for the highest quality. The document is subject to parallel public consultation by the European Commission, WHO, and PIC/S.


ICH has published: Q12  Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

This guideline applies to pharmaceutical drug substances (i.e., active pharmaceutical ingredients) and pharmaceutical drug products, including marketed chemical, and biotechnological/biological products. The guideline also applies to drug-device combination products that meet the definition of a pharmaceutical or biotechnological/biological product. Changes needed to comply with revisions to Pharmacopoeial monographs are not in the scope of this guideline.

 Download Our Comprehensive Overview Including Download Links Here (Microsoft Word).

PCS will release an in-depth analysis of the sterile production guidance by the WHO, EMA, and FDA in May.

Apply for a 25% early registration discount here.

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