Skip to main content
SpringerLink
Log in

APEC Pharmaceutical Evaluation Report (PER) Scheme: A Regional Solution for Global Drug Development

  • Good Regulatory Science in Asia/Pacific: Part 2
  • Published:
Drug information journal : DIJ / Drug Information Association Aims and scope Submit manuscript

Abstract

A proposal to adopt a Pharmaceutical Evaluation Report (PER) scheme for regulatory dialogue in the Asia-Pacific Economic Cooperation (APEC) region was made from Taiwan in the APEC Life Science Innovation Forum (LSIF) in Peru in 2008, aiming to overcome the heterogeneous situation. The PER scheme was recommended to the APEC leadership. The history of the PER scheme, the reasons why the scheme is needed, and its benefits are discussed.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Chern HD. Partnership in harmonization with a proposal of APEC Pharmaceutical Evaluation Report (PER) scheme from Taiwan. Presented at the APEC Life Sciences Innovation Forum. Peru, August 14, 2008.

  2. Kroger HC, Tigrid P. Annuaire Europeen 1998. Amsterdam: Martinus Nijhoff; 1998:63.

    Google Scholar 

  3. Cartwright AC, Mathews BR. Pharmaceutical Product Licensing: Requirements for Europe. Informa Health Care; 1991:256.

  4. Alghabban A. Dictionary of Pharmacovigilance. Pharmaceutical Press; 2004:356.

  5. Chern HD. Unpublished data at Center for Drug Evaluation. Taiwan.

  6. Chern HD. Unpublished data at Center for Drug Evaluation. Taiwan.

Download references

Author information

Authors and Affiliations

  1. Division of Resource Development, Center for Drug Evaluation, Taipei, Taiwan

    Chih-Hwa Lin PhD (Director) & Bing Bing Lin PhD, EMBA (Principal Researcher, Adjunct Assistant Professor)

  2. Department of Business Administration and Department of Healthcare Management, Chang Gung University, Tao Yuan, Taiwan

    Bing Bing Lin PhD, EMBA (Principal Researcher, Adjunct Assistant Professor)

  3. Center for Drug Evaluation, 1F, No. 15-1, Sec. 1, Hangjou S. Rd., Taipei, 100, Taiwan

    Herng-Der Chern MD, PhD (Executive Director)

Authors
  1. Chih-Hwa Lin PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Bing Bing Lin PhD, EMBA
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Herng-Der Chern MD, PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Herng-Der Chern MD, PhD.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Lin, CH., Lin, B.B. & Chern, HD. APEC Pharmaceutical Evaluation Report (PER) Scheme: A Regional Solution for Global Drug Development. Ther Innov Regul Sci 43, 305–309 (2009). https://doi.org/10.1177/009286150904300309

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1177/009286150904300309

Key Words

Search

Navigation